Status:
WITHDRAWN
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C Virus (HCV)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Chronic hepatitis C, Genotype 1 or 4
- HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
- Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
- Naive to prior anti-HCV therapy
Exclusion
- Infected with HCV other than Genotype 1 or 4
- Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
- Evidence of liver disease other than HCV
- Active substance abuse
- Use of hematologic growth factors within 90 days prior to study randomization
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01447394
Start Date
March 1 2012
End Date
August 1 2014
Last Update
February 3 2012
Active Locations (100)
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1
Local Institution
San Diego, California, United States, 92114
2
Local Institution
Rochester, New York, United States, 14642
3
Local Institution
Houston, Texas, United States, 77230
4
Local Institution
Vancouver, British Columbia, Canada, V5Z 1H2