Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with chronic hepatitis C, genotype 1b who have either
- Never received any prior treatment for hepatitis C, or
- Relapsed after an initially successful treatment with alfa + ribavirin
Peginterferon lambda-1a (also called Lambda) is an experimental drug being studied for the treatment of hepatitis B and C. Lambda is an injectable medication and is in the same class of interferon drugs as peginterferon alfa-2a (also called alfa). Because of the differences in the way Lambda and alfa bind to cells, there may be fewer side effects associated with Lambda treatment.
Daclatasvir is an experimental drug and not FDA-approved. Daclatasvir is part of a new class of antiviral drugs being studied in combination with interferon + RBV in the treatment of hepatitis C. These drugs have been shown to have specific activity against hepatitis C and little significant side effects. Combining antiviral drugs with Lambda+RBV or alfa+RBV could make treatment for hepatitis C more effective.
Alfa and telaprevir are FDA-approved for treating hepatitis C.
The purpose of this study is to determine if treatment with Lambda, given in combination with ribavirin and daclatasvir for 24 weeks, is safe and effective as compared to the standard treatment with alfa + ribavirin + telaprevir.
Study participants will be randomly assigned to one of two treatment groups:
- Group 1:
- Lambda self-injected subcutaneously (under the skin) once a week for up to 24 weeks
- Ribavirin by mouth twice a day for up to 24 weeks
- Daclatasvir by mouth once a day for up to 24 weeks
- Group 2:
- Alfa self-injected subcutaneously once a week for up to 48 weeks
- Ribavirin by mouth twice a day for up to 48 weeks
- Telaprevir by mouth 3 times a day for up to 12 weeks
Study participation is expected to be 48 to 72 weeks (including study treatment and post-treatment follow-up), depending on which treatment group a participant is assigned to and response to treatment.
Disease Status and/or Stage
Chronic Hepatitis C, Untreated or Previously Treated
Sponsor
Bristol-Myers Squibb
Key Eligibility
- Men and women age 18 and older
- Chronic Hepatitis C Genotype 1b, and either:
- No previous treatment for hepatitis C, or
- Relapsed after an initially successful treatment with alfa + ribavirin
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Hepatitis Research Team
- 646-962-HEPC (4372)
Protocol ID
BMS AI452021
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
