Status:
COMPLETED
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucl...
Eligibility Criteria
Inclusion
- Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
- Have been infected with Hepatitis C virus for greater than (\>) 6 months
- Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
- Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
- Female subjects must have a negative pregnancy test at all visits before the first dose.
Exclusion
- Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
- Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
- Diagnosed or suspected hepatocellular carcinoma.
- Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
- Alcohol/drug abuse or excessive use in the last 12 months.
- Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00372385
Start Date
August 1 2006
End Date
June 1 2008
Last Update
July 23 2014
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