Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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) ribonucleic acid (RNA) levels

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).