drugset / Trial / NCT01616524

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

NCT01616524

Phase 3 Completed 880 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Timeline

Start
2012-07
Primary completion
2014-06
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Daclatasvir Small molecule 60 mg Oral
Subject Peginterferon Lambda-1a Protein / enzyme biologic 180 ug Subcutaneous
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 400 mg Oral