Phase 3 Study to Evaluate the Efficacy and Safety of Peginterferon Lambda for 48 Weeks in Patients With Chronic HDV

Ведущий спонсор: Eiger BioPharmaceuticals

The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

This is a randomized, open-label, parallel arm study that will allocate patients (2:1) with chronic HDV infection to one of two treatment groups: Peginterferon Lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=100), or no treatment for 12 weeks followed by Peginterferon Lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=50). All patients will receive concomitant therapy with a potent 2nd generation anti-HBV nucleos(t)ide analogue (NUC) throughout the study duration. Data collected during Peginterferon Lambda treatment in Arm 2 will not be included in the primary analysis. The primary purpose of Arm 2 is to provide benchmark data in a parallel reference group for the expected rate of HDV RNA suppression among patients with chronic HDV infection who receive 12 weeks of anti-HBV NUC therapy alone. Prior to randomization, all patients will enter a run-in phase with 12 weeks of anti-HBV NUC therapy, which will ensure virologic control of HBV (< 100 IU/mL) prior to randomization and start of Peginterferon Lambda therapy.

• Hepatitis Delta Virus

Тип вмешательства: Drug

Название вмешательства: Peginterferon Lambda-1a

Описание: Immunomodulator

Этикетка Arm Group: Peginterferon Lambda for 48 weeks

Критерии:

Inclusion Criteria: - Chronic HDV infection documented by a positive HDV antibody test or a positive HDV RNA by RT PCR test for at least 6 months prior to Screening - Quantifiable HDV RNA by RT-PCR test at Screening - Documented confirmed suppression of HBV DNA (< 100 IU/mL) following at least 12 weeks of anti-HBV NUC treatment with ETV or a TNF-based NUC (TDF or TAF) - Serum ALT > upper limit of normal (ULN) and < 10 × ULN. - Patients categorized with Child-Turcotte-Pugh score of ≤ 5 with well compensated liver disease. Exclusion Criteria: - History or current evidence of decompensated liver disease (episodes of variceal bleeding, ascites or encephalopathy) - Treatment with interferons (IFNs) or immunomodulators within 12 months of randomization or refractory to prior IFN treatment.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

70 Years

Здоровые волонтеры:

No

Фамилия: Nicole Ramza, MBA

Телефон: 650-272-6138

Belgium

Bulgaria

France

Germany

Israel

Italy

Moldova, Republic of

Romania

Russian Federation

Spain

Turkey

Ukraine

United States

2022-01-01

Тип: Sponsor

• HDV
• Hepatitis D
• Viral Hepatitis

• Hepatitis A
• Hepatitis D
• Hepatitis

Метка: Peginterferon Lambda for 48 weeks

Тип: Experimental

Описание: Peginterferon Lambda 180 mcg once weekly for 48 weeks with 24 weeks follow-up

Метка: No treatment for 12 weeks

Тип: No Intervention

Описание: No treatment for 12 weeks followed by Peginterferon Lambda 180 mcg once weekly for 48 weeks and 24 weeks follow-up

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: None (Open Label)