Status:
COMPLETED
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) ...
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 Pegylated Interferon 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 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 :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00336479
Start Date
June 1 2006
End Date
February 1 2008
Last Update
July 23 2014
Active Locations (37)
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1
Call For Information
Phoenix, Arizona, United States
2
Cedars-Sinai Medical Center
Los Angeles, California, United States
3
Stanford University Liver Research
Palo Alto, California, United States
4
Call For Information
San Francisco, California, United States