NCT01447394

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

A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus (HCV)

Interventions

Type	Name	Description
BIOLOGICAL	Pegylated Interferon Lambda	Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
BIOLOGICAL	Pegylated Interferon Alfa-2a	Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
DRUG	Ribavirin	Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-03-01
• Completion: 2014-08-01
• First posted: 2011-10-06
• Last updated: 2012-02-03

Locations

100 sites across 20 countries: United States, Canada, China, Colombia, Czechia, Egypt, Hong Kong, Hungary, India, Ireland, Netherlands, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom