drugset / Trial / NCT01447394

Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

NCT01447394

Phase 3 Withdrawn Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Timeline

Start
2012-03
Primary completion
2014-03
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon Lambda-1a Protein / enzyme biologic 180 ug Subcutaneous
Comparator Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral