Открытое расширенное исследование и исследование для участников с болезнью Крона, ранее участвовавших в исследовании фазы III этролизумаба GA29144

Название протокола
Клинические исследование Болезнь Крона: Этролизумаб - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Hoffmann-La Roche

Источник Hoffmann-La Roche
Краткое содержание

Это открытое исследование по расширению и мониторингу безопасности состоит из двух частей: Часть 1 будет оценить долгосрочную безопасность и эффективность продолжения лечения этролизумабом у участников сью Крона средней и тяжелой формы в активной фазе, которые ранее были болезни в включении. этролизумаб, фаза III исследования GA29144 (NCT02394028), которые соответствуют критериям отбора для участие в Части 1. В Части 2 участника, прекратившие лечение этролизумабом. (либо выйдя из Части 1 этого исследования, либо войти непосредственно из исследования GA29144 [NCT02394028]) будет наблюдаться в течение 92 недель на предмет прогрессирующей мультифокальной лейкоэнцефалопатии. (PML) и другие события, связанные с безопасностью.

Общий статус Рекрутинг
Дата начала 2015-06-08
Дата завершения 2026-05-21
Дата первичного завершения 2026-05-21
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Part 1: Number of Participants with Crohn's Disease Activity Index (CDAI) Remission Over Time Weeks 0, 12, 24, and every 12 weeks thereafter until study completion or early withdrawal, commercial availability of etrolizumab, or study termination, whichever is earliest (up to approximately 10 years)
Часть 1: Число участников с клинической ремиссией с течением времени 0, 12, 24 недели и каждые 12 недель после этого до завершения исследования или досрочного прекращения исследования, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Простая эндоскопическая оценка болезни Крона (SES-CD) Оценка на неделе 108 Неделя 108 (или при досрочной отмене, если до 108 недели)
Часть 1: Общее количество участников, у которых возникло хотя бы одно нежелательное явление, по степени тяжести, в соответствии с Общими критериями терминологии для нежелательных явлений Национального института рака, версия 4.0 (NCI-CTCAE v4.0) С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Общее количество участников с нежелательными явлениями, приведшими к прекращению приема этролизумаба С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Общее количество участников, у которых возникло хотя бы одно нежелательное явление, связанное с инфекцией, по степени тяжести, согласно NCI-CTCAE v4.0 С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Число связанных с инфекцией нежелательных явлений на пациента-год С недели 0 до завершения исследования или досрочного прекращения исследования, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Общее количество участников, у которых было хотя бы одно серьезное нежелательное явление, связанное с инфекцией С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Общее количество участников, у которых возникла хотя бы одна реакция в месте инъекции, по степени тяжести, согласно NCI-CTCAE v4.0 С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Общее количество участников, у которых развиваются злокачественные новообразования С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Количество злокачественных новообразований на пациента в год С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Общее количество участников, у которых возникла хотя бы одна реакция гиперчувствительности, по степени тяжести, согласно NCI-CTCAE v4.0 С 0 недели до завершения наблюдения за безопасностью, коммерческой доступности этролизумаба или прекращения исследования, в зависимости от того, что наступит раньше (примерно до 10 лет)
Часть 1: Количество участников с антитерапевтическими антителами (АТА) к этролизумабу Неделя 0 и 12, а затем каждые 48 недель до завершения исследования или досрочного прекращения исследования (примерно до 10 лет)
Часть 2: Число участников, у которых было хотя бы одно предполагаемое или подтвержденное событие прогрессирующей мультифокальной лейкоэнцефалопатии (ПМЛ) От окончания наблюдения за безопасностью до завершения 92-недельного мониторинга безопасности в Части 2 (до 92 недель)
Регистрация 900
Состояние
  • Болезнь Крона
Вмешательство

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Этролизумаб

Описание: 105 мг этролизумаба подкожно один раз в 4 недели

Этикетка Arm Group: Часть 1: Открытое расширение этролизумаба

Другое имя: RG7413

Приемлемость

Критерии:

Критерии включения: Часть 1 Расширение Open-Label: - Пациенты, ранее участвовавшие в исследовании III фазы этролизумаба GA29144 (NCT02394028), которые соответствуют критериям отбора этролизумаба открытого типа, как описано в протоколе Часть 2 Мониторинг безопасности: - Пациенты, которые участвовали в исследовании III фазы этролизумаба GA29144 (NCT02394028) и не соответствует требованиям или решил не участвовать в Части 1 - Пациенты, переведенные из Части 1 - Завершение 12-недельного контрольного периода перед входом Критерий исключения: Часть 1 Расширение Open-Label: - Любое новое, значимое, неконтролируемое состояние. Часть 2 Мониторинг безопасности: - Нет критериев исключения

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Clinical Trials Study Director Hoffmann-La Roche
Общий контакт

Фамилия: Reference Study ID Number: GA29145 https://forpatients.roche.com/

Телефон: 888-662-6728 (U.S. and Canada)

Расположение
Объект: Положение дел:
Moore Clinical Trials, LLC | Sherwood, Arkansas, 72120, United States Withdrawn
Valley Gastroenterology Consultants | Arcadia, California, 91006, United States Active, not recruiting
Ventura County Gastroenterology | Camarillo, California, 93012, United States Withdrawn
Valley View Internal Medicine | Garden Grove, California, 92845, United States Withdrawn
Valley Gastroenterology Cnslts | Glendora, California, 91741, United States Withdrawn
University of California San Diego Medical Center | La Jolla, California, 92093-5354, United States Active, not recruiting
Therapeutic Research Institute of Orange County | Laguna Hills, California, 92653, United States Withdrawn
VA Long Beach Healthcare System | Long Beach, California, 90822, United States Active, not recruiting
California Medical Research Associates, Inc. | Northridge, California, 91324, United States Withdrawn
University of California, Irvine Medical Center | Orange, California, 92868, United States Withdrawn
Digestive Care Associates, A Medical Corporation | San Carlos, California, 94070, United States Active, not recruiting
SDG Clinical Research | San Diego, California, 92103, United States Active, not recruiting
Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri | San Francisco, California, 94158, United States Active, not recruiting
United Gastroenterologists, Inc | Temecula, California, 92592, United States Withdrawn
Ventura Clinical Trials | Ventura, California, 93003, United States Withdrawn
ABS Health, LLC | Whittier, California, 90602, United States Withdrawn
Peak Gastroenterology Associates | Colorado Springs, Colorado, 80907, United States Active, not recruiting
Rocky Mountain Gastroenterology Associates | Denver, Colorado, 80222, United States Withdrawn
Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology | Lakewood, Colorado, 80215, United States Withdrawn
Medical Research Center of Connecticut, LLC | Hamden, Connecticut, 06518, United States Withdrawn
Innovative Medical Research of South Florida | Aventura, Florida, 33180, United States Active, not recruiting
West Central Gastroenterology d/b/a Gastro Florida | Clearwater, Florida, 33762, United States Active, not recruiting
GastroCare; Digestive Care Research | Coral Springs, Florida, 33065, United States Withdrawn
Jesscan Medical Research | Doral, Florida, 33172, United States Withdrawn
University of Florida College of Medicine | Gainesville, Florida, 32610, United States Active, not recruiting
The Center for Gastrointestinal Disorders | Hollywood, Florida, 33021, United States Withdrawn
Borland-Groover Clinic | Jacksonville, Florida, 32256, United States Completed
Borland-Groover Clinic | Jacksonville, Florida, 32256, United States Withdrawn
Florida Center for Gastroenterology | Largo, Florida, 33777, United States Withdrawn
Center for Advanced Gastroenterology | Maitland, Florida, 32751, United States Withdrawn
IMIC, Inc | Miami Beach, Florida, 33140, United States Completed
City Medical Group | Miami, Florida, 33130, United States Withdrawn
Advanced Clinical Research of Miami | Miami, Florida, 33155, United States Withdrawn
Regenerate Clinical Trials | Miami, Florida, 33155, United States Withdrawn
FQL Research, LLC | Miramar, Florida, 33025, United States Completed
Gastroenterology Group of Naples | Naples, Florida, 34102, United States Withdrawn
Advanced Research Institute | New Port Richey, Florida, 34653, United States Withdrawn
Med-Care Research | North Miami Beach, Florida, 33162, United States Withdrawn
Medical Research Group of Central Florida | Orange City, Florida, 32763, United States Withdrawn
Internal Medicine Specialists | Orlando, Florida, 32806, United States Withdrawn
International Clinical Research | Sanford, Florida, 32771, United States Withdrawn
University of South Florida | Tampa, Florida, 33612, United States Withdrawn
Advanced Research Institute, Inc. | Trinity, Florida, 34655, United States Withdrawn
Cleveland Clinic Florida - Weston; Department of Gastroenterology | Weston, Florida, 33331, United States Withdrawn
Shafran Gastroenterology Center | Winter Park, Florida, 32789, United States Completed
Emory University Hospital | Atlanta, Georgia, 30308, United States Active, not recruiting
Agile Clinical Research Trials | Atlanta, Georgia, 30328, United States Withdrawn
Atlanta Gastroenterology Associates | Atlanta, Georgia, 30342, United States Active, not recruiting
Atlanta Gastroenterology Associates | Atlanta, Georgia, 30342, United States Withdrawn
Columbus Regional Research Institute | Columbus, Georgia, 31904, United States Active, not recruiting
Atlanta Center for Gastroenterology, PC | Decatur, Georgia, 30033, United States Completed
Gastroenterology Associates of Central Georgia | Macon, Georgia, 31201, United States Active, not recruiting
Gastrointestinal Specialists of Georgia, PC | Marietta, Georgia, 30060, United States Active, not recruiting
Atlanta Gastroenterology Specialists, PC | Suwanee, Georgia, 30024, United States Withdrawn
Grand Teton Research Group, PLLC | Idaho Falls, Idaho, 83404, United States Withdrawn
Advanced Clinical Research | Meridian, Idaho, 83642, United States Active, not recruiting
Northwestern Uni-Feinberg School of Medicine | Chicago, Illinois, 60611, United States Active, not recruiting
University of Chicago Medical Center | Chicago, Illinois, 60637, United States Active, not recruiting
NorthShore University HealthSystem; Evanston Hospital | Evanston, Illinois, 60201, United States Withdrawn
Southwest Gastroenterology | Oak Lawn, Illinois, 60453, United States Active, not recruiting
Carle Foundation Hospital | Urbana, Illinois, 61801-2500, United States Completed
Investigators Research Group, LLC | Brownsburg, Indiana, 46112, United States Withdrawn
Indiana University | Indianapolis, Indiana, 46202, United States Withdrawn
Aquiant Research | New Albany, Indiana, 47150, United States Withdrawn
Iowa Digestive Disease Center | Des Moines, Iowa, 50312, United States Withdrawn
Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka, Kansas, 66606, United States Active, not recruiting
University of Louisville | Elizabethtown, Kentucky, 42791, United States Withdrawn
University of Kentucky Medical Center | Lexington, Kentucky, 40536, United States Withdrawn
Gastroenterology Associates, LLC | Baton Rouge, Louisiana, 70809, United States Completed
Houma Digestive Health | Houma, Louisiana, 70360, United States Withdrawn
Louisiana Research Center, LLC | Shreveport, Louisiana, United States Active, not recruiting
Chevy Chase Clinical Research | Chevy Chase, Maryland, 20815, United States Withdrawn
Gastro Associates | Elkridge, Maryland, 21075, United States Withdrawn
Gastroenterology Associates | Elkridge, Maryland, 21075, United States Withdrawn
Charm City Research - Prn | Towson, Maryland, 21204, United States Withdrawn
Massachusetts General Hospital; Crohn's & Colitis Center | Boston, Massachusetts, 02114, United States Withdrawn
Commonwealth Clinical Studies | Brockton, Massachusetts, 02302, United States Withdrawn
Community Clinical Research Network | Marlborough, Massachusetts, 01752, United States Withdrawn
University of Michigan | Ann Arbor, Michigan, 48109, United States Active, not recruiting
Clin. Rsrch Inst. of Michigan | Chesterfield, Michigan, 48047, United States Withdrawn
Gastroenterology Associates of Western Michigan, P.L.C. | Grand Rapids, Michigan, 49506, United States Active, not recruiting
The iResearch Group, LLC | Southfield, Michigan, 58304, United States Withdrawn
Center for Digestive Health | Troy, Michigan, 48098, United States Active, not recruiting
Henry Ford Health System | West Bloomfield, Michigan, 48322, United States Completed
Mayo Clinic - Rochester | Rochester, Minnesota, 55905, United States Active, not recruiting
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Completed
Ehrhardt Clinical Research, LLC | Belton, Missouri, 64012, United States Completed
Quality Clinical Research | Omaha, Nebraska, 68114, United States Withdrawn
Gastroenterology Associates of New Jersey | Clifton, New Jersey, 07013, United States Withdrawn
Atlantic Digestive Health Institute at Morristown | Morristown, New Jersey, United States Withdrawn
AGA Clinical Research Associates, LLC | Twp, New Jersey, 08234, United States Withdrawn
Gastroenterology Group of South Jersey | Vineland, New Jersey, 08360, United States Withdrawn
Allied Gastrointestinal Associates, PA | Voorhees, New Jersey, 08043, United States Withdrawn
Long Island Clin Rsch Asc, LLP | Great Neck, New York, 11021, United States Withdrawn
North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation | New Hyde Park, New York, United States Withdrawn
Concorde Medical Group | New York, New York, 10016, United States Withdrawn
Concorde Medical Group | New York, New York, 10016, United States Completed
Weill Cornell Medical College-New York Presbyterian Hospital | New York, New York, 10021, United States Active, not recruiting
Westside Internal Medicine | New York, New York, 10024, United States Withdrawn
M.D. Gastroenterology | New York, New York, 10028, United States Withdrawn
Mount Sinai - PRIME | New York, New York, 10029, United States Withdrawn
Lenox Hill Hospital | New York, New York, 10075, United States Active, not recruiting
Premier Medical Group of the Hudson Valley PC | Poughkeepsie, New York, 12601, United States Withdrawn
Asheville Gastroenterology Associates, P.A.; Gastroenterology | Asheville, North Carolina, 28801, United States Withdrawn
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, 27599, United States Active, not recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte, North Carolina, 28207, United States Active, not recruiting
Cumberland Research Associates, Llc | Fayetteville, North Carolina, 28304, United States Withdrawn
Clinical Research of Gastonia | Gastonia, North Carolina, 28054, United States Withdrawn
Atlantic Medical Group | Kinston, North Carolina, 28501, United States Withdrawn
Kinston Medical Specialists | Kinston, North Carolina, 28501, United States Active, not recruiting
Consultants for Clinical Research Inc. | Cincinnati, Ohio, 45219, United States Completed
UC Health Clinical Trials Office | Cincinnati, Ohio, 45267, United States Withdrawn
Cleveland Clinic Foundation | Cleveland, Ohio, 44915, United States Withdrawn
Advanced Medical Research | Maumee, Ohio, 43537, United States Withdrawn
Great Lakes Gastroenterology Research, LLC | Mentor, Ohio, 44060, United States Active, not recruiting
Central Sooner Research | Norman, Oklahoma, 73012, United States Withdrawn
University of Oklahoma Health Sciences Center; Stephenson Cancer Center | Oklahoma City, Oklahoma, 73104, United States Withdrawn
Digestive Disease Specialists, Inc. | Oklahoma City, Oklahoma, 73112, United States Active, not recruiting
Great Lakes Medical Research, LLC | Harrisburg, Pennsylvania, 17110, United States Active, not recruiting
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Withdrawn
Innovative Clinical Research | Greenville, South Carolina, 29604, United States Completed
Clinical Trials of South Carolina | North Charleston, South Carolina, 29406, United States Withdrawn
Clinical Research of Rock Hill | Rock Hill, South Carolina, 29732, United States Withdrawn
Gastro One | Germantown, Tennessee, 38138, United States Active, not recruiting
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States Active, not recruiting
Texas Physicians Medical Research Group, LLC | Arlington, Texas, 76015, United States Withdrawn
Texas Digestive Disease Consultants - Dallas | Dallas, Texas, 75231, United States Not yet recruiting
University of Texas Southwestern Medical Center; Internal Medicne | Dallas, Texas, 75390-9151, United States Active, not recruiting
Baylor College of Medicine | Houston, Texas, 77030, United States Completed
Methodist Hospital Research Institute | Houston, Texas, 77030, United States Active, not recruiting
Gastroenterology Research of San Antonio, LLC | San Antonio, Texas, 78229, United States Withdrawn
Wellness Clinical Research Center | San Antonio, Texas, 78232, United States Active, not recruiting
Texas Digestive Disease Consultants - Southlake | Southlake, Texas, 76092, United States Active, not recruiting
Texas Digestive Disease Consultants | Southlake, Texas, 76092, United States Withdrawn
Digestive Health Specialists of Tyler | Tyler, Texas, 75701, United States Active, not recruiting
Ericksen Research and Development | Clinton, Utah, 84015, United States Completed
Advanced Research Institute | Ogden, Utah, 84405, United States Withdrawn
University of Utah School of Medicine | Salt Lake City, Utah, 84132, United States Active, not recruiting
Granger Medical Clinic | West Valley City, Utah, 84120, United States Withdrawn
University of Virginia; Gastroenterology and Hepatology | Charlottesville, Virginia, 22908, United States Withdrawn
Digestive and Liver Disease Specialists, Ltd. | Norfolk, Virginia, 23502, United States Withdrawn
McGuire Research Institute; Gastroenterology | Richmond, Virginia, 23249, United States Active, not recruiting
Virginia Commonwealth Uni Health Center | Richmond, Virginia, 23298, United States Withdrawn
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia; Office of Doctor Weiserbs | Roanoke, Virginia, 24014, United States Withdrawn
Digestive Disease Institute; Virginia Mason Medical Center | Seattle, Washington, 98101, United States Active, not recruiting
University of Washington School of Medicine | Seattle, Washington, 98104, United States Withdrawn
Swedish Medical Center | Seattle, Washington, 98122, United States Withdrawn
University of Wisconsin | Madison, Wisconsin, 53792, United States Active, not recruiting
Hospital Italiano | Caba, C1199ABB, Argentina Active, not recruiting
Instituto DAMIC - Fundación Rusculleda | Cordoba, 5003, Argentina Withdrawn
Hospital Italiano de La Plata | La Plata, 1900, Argentina Withdrawn
Asociacion Civil para la Investigacion Gastroenterologica | Lomas de Zamora, B1832IJJ, Argentina Withdrawn
Hospital Privado de Comunidad; Cardiology | Mar Del Plata, B7602CBM, Argentina Withdrawn
Instituto Medico CER | Quilmes, B1878DVB, Argentina Withdrawn
Hospital Provincial del Centenario | Rosario, 2000, Argentina Withdrawn
Instituto Medico de la Fundacion Estudios Clinicos | Rosario, 2000, Argentina Withdrawn
The Canberra Hospital | Garran, Australian Capital Territory, 2065, Australia Active, not recruiting
Bankstown-Lidcombe Hospital | Bankstown, New South Wales, 2200, Australia Withdrawn
Concord Repatriation General Hospital | Concord, New South Wales, 2139, Australia Recruiting
Royal Brisbane and Women's Hospital | Herston, Queensland, 4029, Australia Recruiting
University of the Sunshine Coast | Sippy Downs, Queensland, 4556, Australia Completed
Mater Adult Hospital | South Brisbane, Queensland, 4101, Australia Recruiting
Princess Alexandra Hospital | Woolloongabba, Queensland, 4102, Australia Recruiting
Royal Adelaide Hospital | Adelaide, South Australia, 5000, Australia Withdrawn
Flinders Medical Centre | Bedford Park, South Australia, 5042, Australia Recruiting
Launceston General Hospital; Gastroenterology Research | Launceston, Tasmania, 7250, Australia Withdrawn
Monash Medical Centre Clayton | Clayton, Victoria, 3168, Australia Withdrawn
St Vincent's Hospital Melbourne | Fitzroy, Victoria, 3065, Australia Recruiting
Footscray Hospital | Footscray, Victoria, 3011, Australia Not yet recruiting
Austin Hospital | Heidelberg, Victoria, 3084, Australia Withdrawn
Emeritus Research | Malvern East, Victoria, 3145, Australia Withdrawn
St Frances Xavier Cabrini Hospital | Malvern, Victoria, 3144, Australia Recruiting
Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics | Parkville, Victoria, 3050, Australia Recruiting
The Alfred Hospital | Prahan, Victoria, 3181, Australia Recruiting
Fiona Stanley Hospital | Murdoch, Western Australia, 6150, Australia Recruiting
Medizinische Universität Innsbruck | Innsbruck, 6020, Austria Withdrawn
Klinikum Klagenfurt am Wörtersee; Abt.Gastroenterologie&Hepatologie,Endokrinologie | Klagenfurt, 9020, Austria Withdrawn
LKH - Universitätsklinikum der PMU Salzburg | Salzburg, 5020, Austria Active, not recruiting
Medizinische Universität Wien | Wien, 1090, Austria Active, not recruiting
UZ Brussel | Brussel, 1090, Belgium Completed
CHU St Pierre (César de Paepe) X | Bruxelles, 1000, Belgium Active, not recruiting
ULB Hopital Erasme; Service de Néphrologie | Bruxelles, 1070, Belgium Active, not recruiting
Cliniques Universitaires St-Luc | Bruxelles, 1200, Belgium Withdrawn
UZ Antwerpen | Edegem, 2650, Belgium Completed
AZ Maria Middelares | Gent, 9000, Belgium Active, not recruiting
AZ Sint Lucas (Sint Lucas) | Gent, 9000, Belgium Withdrawn
AZ Sint Elisabeth Herentals | Herentals, 2200, Belgium Withdrawn
AZ Groeninge | Kortrijk, 8500, Belgium Withdrawn
UZ Leuven; Maag, -darm en leverziekten/endoscopie - Endoscopy | Leuven, 3000, Belgium Withdrawn
AZ Delta (Stedelijk Ziekenhuis) | Roeselare, 8800, Belgium Withdrawn
Hospital Universitario Walter Cantidio - UFC | Fortaleza, CE, 60430-370, Brazil Withdrawn
CCBR - Brasilia | Brasilia, DF, 70200-730, Brazil Withdrawn
CEDOES - Diagnóstico e Pesquisa | Vitoria, ES, 29055-450, Brazil Withdrawn
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiânia, GO, 74535-170, Brazil Active, not recruiting
Hospital Felicio Rocho | Belo Horizonte, MG, 30110-068, Brazil Active, not recruiting
Centro Mineiro de Pesquisa - CMIP | Juiz de Fora, MG, 36010-570, Brazil Withdrawn
Eurolatino Pesquisas Médicas Ltda. | Uberlandia, MG, 38411-186, Brazil Withdrawn
Centro Digestivo de Curitiba | Curitiba, PR, 80430-160, Brazil Active, not recruiting
Hospital Universitario Gaffree e Guinle | Rio de Janeiro, RJ, 20270-004, Brazil Withdrawn
Hospital Universitario Clementino Fraga Filho - UFRJ | Rio de Janeiro, RJ, 21941-913, Brazil Recruiting
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A | Rio de Janeiro, RJ, 22271-100, Brazil Active, not recruiting
Hospital Sao Vicente de Paulo | Passo Fundo, RS, 99010-090, Brazil Active, not recruiting
Hospital das Clinicas - UFRGS | Porto Alegre, RS, 90035-903, Brazil Active, not recruiting
Hospital Ernesto Dornelles | Porto Alegre, RS, 90160-092, Brazil Active, not recruiting
Centro de Pesquisa Clinica Maimonides - Maimonides Day Hospital | Porto Alegre, RS, 90480-000, Brazil Withdrawn
Hospital Sao Lucas da PUCRS*X | Porto Alegre, RS, 90610-000, Brazil Withdrawn
Clinica de Neoplasias Litoral | Itajai, SC, 88301-220, Brazil Withdrawn
Oncoeste Pesquisa Clinica - HUST - Hospital Universitario Santa Terezinha | Joacaba, SC, 89600-000, Brazil Withdrawn
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu | Botucatu, SP, 18618-970, Brazil Active, not recruiting
Allergisa Pesquisa Dermato-Cosmética Ltda | Campinas, SP, 13084-791, Brazil Withdrawn
CAEP - Centro Avancado de Estudos e Pesquisas Ltda. | Campinas, SP, 13087-567, Brazil Withdrawn
Pesquisare Saúde Sociedade Simples | Santo Andre, SP, 09080-000, Brazil Active, not recruiting
Praxis Pesquisa Médica | Santo Andre, SP, 09090-790, Brazil Active, not recruiting
Hospital Estadual Mario Covas | Santo Andre, SP, 09190-610, Brazil Active, not recruiting
Irmandade da Santa Casa da Misericórdia de Santos | Santos, SP, 11075-900, Brazil Withdrawn
Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto, SP, 15090-000, Brazil Active, not recruiting
Hospital Sírio-Libanês | Sao Paulo, SP, 01308-050, Brazil Active, not recruiting
Universidade Federal de Sao Paulo - UNIFES | Sao Paulo, SP, 04026-000, Brazil Active, not recruiting
Hospital do Servidor Público Estadual/HSPE-SP | São Paulo, SP, 04039-901, Brazil Active, not recruiting
Medical Centre "Asklepii", OOD | Dupnitsa, 2600, Bulgaria Withdrawn
MHAT "Lyulin", EAD | Sofia, 1336, Bulgaria Withdrawn
"City Clinic UMHAC" EOOD | Sofia, 1407, Bulgaria Not yet recruiting
DCC "Sarce i Zdrave", OOD | Sofia, 1407, Bulgaria Withdrawn
MHAT Tokuda Hospital Sofia, AD | Sofia, 1407, Bulgaria Withdrawn
UMHAT "Sv. Ivan Rilski", EAD | Sofia, 1431, Bulgaria Recruiting
UMHAT Tsaritsa Yoanna - ISUL, EAD | Sofia, 1527, Bulgaria Withdrawn
Military Medical Academy - MHAT - Sofia | Sofia, 1606, Bulgaria Withdrawn
MC "Health BG", EOOD | Sofia, 1680, Bulgaria Withdrawn
MHAT SofiaMed; OOD | Sofia, Bulgaria Withdrawn
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD | Stara Zagora, 6000, Bulgaria Withdrawn
UMHAT Sv. Marina EAD | Varna, 9010, Bulgaria Withdrawn
MHAT 'Hristo Botev' AD | Vratsa, 3000, Bulgaria Withdrawn
University of Calgary | Calgary, Alberta, T2N 2T9, Canada Active, not recruiting
Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology | Edmonton, Alberta, T6G 2X8, Canada Active, not recruiting
(G.I.R.I.) GI Research Institute | Vancouver, British Columbia, V6Z 2K5, Canada Active, not recruiting
Winnipeg Regional Health Authority; Neurosurgery Department | Winnipeg, Manitoba, R3A 1R9, Canada Active, not recruiting
Queen Elizabeth II Health Sciences Centre; Gastroenterology Research | Halifax, Nova Scotia, B3H 1V7, Canada Active, not recruiting
McMaster University Health Sciences Center | Hamilton, Ontario, L8N 3Z5, Canada Withdrawn
Hotel Dieu Hospital; Gastroenterology | Kingston, Ontario, K7L 5G2, Canada Withdrawn
University Hospital - London Health Sciences Centre | London, Ontario, N6A 5A5, Canada Completed
Taunton Health Centre | Oshawa, Ontario, L1H 7K4, Canada Completed
The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit | Ottawa, Ontario, K1H 1A2, Canada Active, not recruiting
Northeastern Ontario Medical Offices | Sudbury, Ontario, P3E 6C3, Canada Withdrawn
Humber River Hospital | Toronto, Ontario, M3M 0B2, Canada Withdrawn
Mount Sinai Hospital | Toronto, Ontario, M5G 1X5, Canada Active, not recruiting
Toronto Western Hospital | Toronto, Ontario, M5T 2S8, Canada Withdrawn
Toronto Liver Centre | Toronto, Ontario, M6H 3M1, Canada Withdrawn
Toronto Digestive Disease Associates | Vaughan, Ontario, L4L 4Y7, Canada Completed
Hotel Dieu de Levis | Levis, Quebec, G6V 3Z1, Canada Withdrawn
Hôpital Maisonneuve - Rosemont | Montreal, Quebec, H1T 2M4, Canada Active, not recruiting
Jewish General Hospital; Endoscopy Department | Montreal, Quebec, H3T 1E2, Canada Withdrawn
McGill University Health Centre - Glen Site | Montreal, Quebec, H4A 3J1, Canada Active, not recruiting
Royal University Hospital | Saskatoon, Saskatchewan, S7N 0W8, Canada Active, not recruiting
Clinical Hospital Centre Osijek | Osijek, 31000, Croatia Active, not recruiting
General Hospital Pula | Pula, 52100, Croatia Active, not recruiting
General Hospital Zadar | Zadar, 23000, Croatia Withdrawn
Clinical Hospital Merkur; Coronary Care Unite | Zagreb, 10 000, Croatia Withdrawn
Clinical Hospital Center Sestre Milosrdnice | Zagreb, 10000, Croatia Active, not recruiting
Clinical Hospital Centre Zagreb | Zagreb, 10000, Croatia Not yet recruiting
Clinical Hospital Sveti Duh | Zagreb, 10000, Croatia Withdrawn
Vojenska nemocnice Brno | Brno, 636 00, Czechia Recruiting
Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika | Brno, 65691, Czechia Recruiting
Nemocnice Ceske Budejovice a.s. | Ceske Budejovice, 370 01, Czechia Not yet recruiting
Gastroenterologie s.r.o. | Hradec Kralove, 500 02, Czechia Recruiting
Fakultni nemocnice Hradec Kralove | Hradec Kralove, 500 05, Czechia Recruiting
Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove, 500 12, Czechia Recruiting
PreventaMed, s.r.o. | Olomouc, 779 00, Czechia Recruiting
Fakultni nemocnice Ostrava | Ostrava - Poruba, 708 52, Czechia Recruiting
Pardubicka krajska nemocnice, a.s. | Pardubice, 532 03, Czechia Withdrawn
Fakultni nemocnice v Motole | Praha 5, 150 06, Czechia Withdrawn
ISCARE a.s. | Praha 7, 170 04, Czechia Recruiting
Fakultni nemocnice Kralovske Vinohrady | Praha, 110 34, Czechia Active, not recruiting
Orlickoustecka nemocnice, a.s. | Usi Nad Orlici, 562 18, Czechia Withdrawn
West Tallinn Central Hospital | Tallinn, 10617, Estonia Active, not recruiting
North Estonia Medical Centre Foundation | Tallinn, 13419, Estonia Active, not recruiting
Tartu University Hospital | Tartu, 51014, Estonia Active, not recruiting
CHU Amiens - Hopital Sud | Amiens, 80054, France Active, not recruiting
CHU de Caen - Hopital Cote de Nacre | Caen, 14033, France Active, not recruiting
CHU Tours - Hôpital Trousseau | Chambray les Tours, 37170, France Withdrawn
CHU Clermont Ferrand - Hôpital d'Estaing | Clermont Ferrand cedex 1, 63003, France Withdrawn
Hôpital Beaujon | Clichy cedex, 92110, France Recruiting
CHU de Grenoble - Hôpital Nord | Grenoble, 38043, France Withdrawn
Centre Hospitalier Départemental Les Oudairies | La Roche sur Yon, 85025, France Withdrawn
Hopital Claude Huriez - CHU Lille | Lille, 59037, France Active, not recruiting
Hôpital Nord - CHU Marseille; Service d'Oncologie Multidisciplinaire | Marseille Cedex 20, 13915, France Withdrawn
CHU NANTES - Hôtel Dieu; Pharmacy | Nantes, 44093, France Active, not recruiting
CHU Nice - Hopital de l'Archet 2 | Nice, 06202, France Active, not recruiting
Hôpital Saint-Louis | Paris, 75475, France Active, not recruiting
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN | Pessac, 33604, France Active, not recruiting
Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie | Pierre-Benite, 69495, France Active, not recruiting
CHU du Reims - Hopital Robert Debré | Reims, 51092, France Active, not recruiting
CHU Rennes - Hopital Pontchaillou | Rennes cedex 09, 35033, France Withdrawn
CHU de Rouen - Hôpital Charles Nicolle; Neurologie | Rouen, 76031, France Withdrawn
CHU Saint Etienne - Hôpital Nord | Saint Etienne, 42055, France Active, not recruiting
Höpital Hautepierre; Pediatrie1 | Strasbourg, 67098, France Active, not recruiting
CHU de Toulouse - Hôpital Rangueil | Toulouse Cedex 09, 31059, France Withdrawn
Hôpital de Brabois Adultes | Vandoeuvre-les-nancy, 54511, France Active, not recruiting
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin, 12200, Germany Withdrawn
Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie | Berlin, 13353, Germany Active, not recruiting
Charité Campus Virchow-Klinikum; Department of Cardiology | Berlin, 13353, Germany Recruiting
DRK Kliniken Berlin Westend | Berlin, 14050, Germany Withdrawn
Krankenhaus Waldfriede e. V. | Berlin, 14163, Germany Active, not recruiting
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH | Bochum, 44789, Germany Active, not recruiting
Staedisches Klinikum Brandenburg | Brandenburg an der Havel, 14770, Germany Not yet recruiting
Medizinisches Versorgungszentrum Dachau | Dachau, 85221, Germany Withdrawn
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden, 01307, Germany Not yet recruiting
Universitaetsklinikum Erlangen | Erlangen, 91054, Germany Withdrawn
Kliniken Essen-Mitte | Essen, 45136, Germany Withdrawn
Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt, 60590, Germany Active, not recruiting
Krankenhaus Martha-Maria Halle-Doelau | Halle (Saale), 06120, Germany Withdrawn
Universitaetsklinikum Halle (Saale) | Halle, 06120, Germany Not yet recruiting
Hamburgisches Forschungsinstitut fuer CED | Hamburg, 20148, Germany Withdrawn
Universitätsklinikum Hamburg-Eppendorf | Hamburg, 20246, Germany Withdrawn
Gastroenterologie | Hamburg, 20249, Germany Withdrawn
Asklepios Klinik Hamburg | Hamburg, 22559, Germany Withdrawn
Medizinische Hochschule Hannover | Hannover, 30625, Germany Active, not recruiting
Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter | Heidelberg, 69121, Germany Withdrawn
Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena | Jena, 07740, Germany Withdrawn
Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel, 24116, Germany Withdrawn
Universitätsklinikum Koeln | Koeln, 50937, Germany Withdrawn
Medizinisches Zentrum Klinikum Lueneburg | Lueneburg, 21339, Germany Withdrawn
Universitätsklinikum Schleswig-Holstein; Campus Lübeck | Lübeck, 23538, Germany Withdrawn
Universitätsklinikum Magdeburg A.ö.R. | Magdeburg, 39120, Germany Withdrawn
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz, 55101, Germany Withdrawn
Klinikum Mannheim GmbH Universitätsklinikum | Mannheim, 68167, Germany Active, not recruiting
Gastroenterologische Praxis Minden | Minden, 32423, Germany Withdrawn
Universitaetsklinikum Muenster | Muenster, 48149, Germany Withdrawn
Gastro Campus Research; Praxis am Germania Campus | Muenster, 48159, Germany Withdrawn
Klinikum rechts der Isar der Technischen Universität München | Munchen, 81675, Germany Withdrawn
Isar Klinik GmbH | München, 80331, Germany Withdrawn
LMU - Campus Grosshadern; Medizinische Klinik und Poliklinik II | München, 81377, Germany Withdrawn
Gemeinschaftspraxis | Offenburg, 77652, Germany Completed
Gemeinschaftspraxis Mohl, Juenglin, Hasenstein | Saarbrücken, 66111, Germany Withdrawn
Universitaetsklinikum Tuebingen | Tuebingen, 72076, Germany Withdrawn
Universitaetsklinikum Ulm | Ulm, 89081, Germany Active, not recruiting
Internistische Praxisgemeinschaft | Weyhe, 28844, Germany Withdrawn
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza | Bekescsaba, 5600, Hungary Active, not recruiting
Szent Margit Hospital | Budapest, 1032, Hungary Withdrawn
Obudai Egeszsegugyi Centrum Kft. | Budapest, 1036, Hungary Active, not recruiting
Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary Withdrawn
Semmelweis Egyetem | Budapest, 1083, Hungary Withdrawn
Semmelweis Egyetem | Budapest, 1083, Hungary Active, not recruiting
Magyar Elhizastudomanyi Kozp. Kft. | Budapest, 1124, Hungary Withdrawn
Szt Janos Korhaz es EbudaiEgyesitettKorhazak | Budapest, 1125, Hungary Completed
Pannonia Maganorvosi Centrum | Budapest, 1135, Hungary Active, not recruiting
Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika | Debrecen, 4012, Hungary Active, not recruiting
Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft | Debrecen, 4025, Hungary Withdrawn
Markhot Ferenc Oktato Korhaz es Rendelointezet | Eger, 3300, Hungary Withdrawn
Petz Aladar Megyei Oktato Korhaz | Gyor, 9024, Hungary Active, not recruiting
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza | Gyula, 5700, Hungary Withdrawn
Pest Megyei Flor Ferenc Korhaz | Kistarcsa, 2143, Hungary Active, not recruiting
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat | Miskolc, 3526, Hungary Withdrawn
Pecsi Tudomanyegyetem | Pecs, 7624, Hungary Not yet recruiting
Csongrad Megyei Dr. Bugyi Istvan Korhaz | Szentes, 6600, Hungary Withdrawn
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár, 8000, Hungary Not yet recruiting
Haemek Medical Center | Afula, 18101, Israel Active, not recruiting
Soroka University Medical Centre | Beer Sheva, 8410101, Israel Active, not recruiting
Assaf Harofeh Medical Center | Beer Yaacov, 6093000, Israel Withdrawn
Bnai Zion Medical Center; Department of Internal Medicine B | Haifa, 31048, Israel Withdrawn
Wolfson Medical Center | Holon, 5822012, Israel Active, not recruiting
Hadassah University Hospital - Ein Kerem; Oncology | Jerusaelm, 9112001, Israel Not yet recruiting
Shaare Zedek Medical Center | Jerusalem, 9103102, Israel Active, not recruiting
Clalit Health Services-Lev Talpiyot | Jerusalem, 95146, Israel Withdrawn
Holy Family Hospital | Nazareth, 16100, Israel Active, not recruiting
Rabin Medical Center-Beilinson Campus | Petach Tikva, 4941492, Israel Active, not recruiting
Chaim Sheba Medical Center | Ramat Gan, 5265601, Israel Withdrawn
Kaplan Medical Center; Allergy and clinical immunology | Rechovot, 7610001, Israel Withdrawn
Tel Aviv Sourasky Medical Center; Pharmacy | Tel Aviv, 6423906, Israel Completed
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh | Bologna, Emilia-Romagna, 40138, Italy Withdrawn
A.O.U. Policlinico di Modena | Modena, Emilia-Romagna, 40124, Italy Active, not recruiting
Azienda Ospedaliero Universitaria di Parma; Clinica Pediatrica | Parma, Emilia-Romagna, 43100, Italy Withdrawn
Azienda Ospedaliera San Camillo Forlanini | Roma, Lazio, 00152, Italy Active, not recruiting
Policlinico Universitario Agostino Gemelli; Farmacia | Roma, Lazio, 00168, Italy Active, not recruiting
Azienda Ospedaliero Universitaria San Martino | Genova, Liguria, 16132, Italy Withdrawn
Asst Fatebenefratelli Sacco (Fatebenefratelli) | Milano, Lombardia, 20121, Italy Active, not recruiting
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco) | Milano, Lombardia, Italy Withdrawn
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda) | Milano, Lombardia, Italy Withdrawn
Fondazione IRCCS Policlinico San Matteo | Pavia, Lombardia, 27100, Italy Withdrawn
Ospedale di Circolo | Rho, Lombardia, 20017, Italy Withdrawn
Istituto Clinico Humanitas | Rozzano (MI), Lombardia, 20089, Italy Active, not recruiting
I.R.C.C.S Policlinico San Donato | San Donato Milanese (MI), Lombardia, 20097, Italy Active, not recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Milano, Molise, 20122, Italy Withdrawn
Ospedale Umberto I di Torino | Torino, Piemonte, 10128, Italy Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico G. Martino; Dip. sperimentale Medicina e Farmacologia | Messina, Sicilia, 98122, Italy Withdrawn
Azienda Ospedaliera Vincenzo Cervello | Palermo, Sicilia, 90127, Italy Withdrawn
Azienda Ospedaliera Universitaria Careggi | Firenze, Toscana, 50141, Italy Active, not recruiting
Azienda Ospedaliero Universitaria Pisana | Pisa, Toscana, 56100, Italy Withdrawn
Azienda Ospedaliera di Padova | Padova, Veneto, 35128, Italy Withdrawn
Inje University Busan Paik Hospital | Busan, 47392, Korea, Republic of Withdrawn
Dong-A University Hospital | Busan, 49201, Korea, Republic of Recruiting
Pusan National University Hospital | Busan, 49241, Korea, Republic of Withdrawn
Keimyung University Dongsan Hospital | Daegu, 41931, Korea, Republic of Withdrawn
Kyungpook National University Hospital | Daegu, 41944, Korea, Republic of Recruiting
Yeungnam Univ. Hospital | Daegu, 705-717, Korea, Republic of Completed
Hanyang University Guri Hospital | Gyeonggi-do, 11923, Korea, Republic of Withdrawn
Korea University Ansan Hospital | Gyeonggi-do, 15355, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13605, Korea, Republic of Recruiting
CHA Bundang Medical Centre; CHA university | Seongnam, 13520, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Not yet recruiting
Kangbuk Samsung Hospital | Seoul, 03181, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic of Withdrawn
Asan Medical Center | Seoul, 05505, Korea, Republic of Completed
Samsung Medical Center | Seoul, 06351, Korea, Republic of Completed
The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, 137-701, Korea, Republic of Withdrawn
The Catholic University of Korea St. Vincent's Hospital | Suwon-si,, 442-723, Korea, Republic of Withdrawn
Yonsei University Wonju Severance Christian Hospital | Wonju-Si, 220-701, Korea, Republic of Recruiting
Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy | Riga, LV-1005, Latvia Active, not recruiting
Pauls Stradins Clinical University Hospital | Rīga, LV-1002, Latvia Completed
Digestive Diseases Center "Gastro" | Rīga, LV-1079, Latvia Withdrawn
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics | Kaunas, 50009, Lithuania Active, not recruiting
Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology | Vilnius, 08661, Lithuania Active, not recruiting
Hopitaux Robert Schuman | Luxembourg, 2540, Luxembourg Withdrawn
Gastro Medical | Mexicali, BAJA California, 21100, Mexico Withdrawn
Clinical Research Institute | Tlalnepantla de Baz, Mexico CITY (federal District), 54055, Mexico Active, not recruiting
Centro Regiomontano de Es