Status:
COMPLETED
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 inf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01795911
Start Date
March 1 2013
End Date
September 1 2014
Last Update
October 9 2015
Active Locations (1)
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1
Alamo Medical Research
San Antonio, Texas, United States, 78215