drugset / Trial / NCT02731131

A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

NCT02731131 ↗

Phase 2 Completed 12 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

Timeline

Start
2004-09
Primary completion
2009-05
Completion
2009-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin; p = 0.30; Fisher Exact NCT02731131 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Subject Ribavirin Small molecule 1000 mg Oral
Subject Ribavirin Small molecule 1200 mg Oral