Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | March 2013 |
| End Date: | September 2014 |
A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects
Substudy C: The purpose of this substudy is to determine whether Lambda combined with
Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with
genotype 1b chronic HCV infection
Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with
genotype 1b chronic HCV infection
Inclusion Criteria:
- Chronic Hepatitis C, Genotype 1
- HCV RNA >100,000 IU/mL at screening;
- Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen
(HBsAg);
- Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and
will be capped at approximately 10%
Exclusion Criteria:
- Any evidence of liver disease other than HCV;
- Co-infection with HIV;
- Diagnosed or suspected hepatocellular carcinoma;
- Medical history or laboratory value abnormalities that would prohibit the use of
Pegylated Interferon Alpha-2a or Ribavirin
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