Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Chronic hepatitis C, Genotype 2 or 3

- Naïve to prior anti-HCV therapy

Exclusion Criteria:

- Infected with HCV other than Genotype 2 or 3

- Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1
(HIV-1)/HIV-2 antibody at screening

- Evidence of liver disease other than HCV

- Active substance abuse

- Evidence of decompensated cirrhosis