Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00336479
First received: June 9, 2006
Last updated: June 22, 2011
Last verified: June 2011

June 9, 2006
June 22, 2011
June 2006
February 2008   (final data collection date for primary outcome measure)
Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 24 Weeks After the Completion of the Assigned Study Drug Regimen [ Time Frame: 24 weeks after the completion of study drug dosing ] [ Designated as safety issue: No ]
Plasma HCV RNA 24 weeks post-treatment
Complete list of historical versions of study NCT00336479 on ClinicalTrials.gov Archive Site
  • Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 12 Weeks After the Completion of the Assigned Study Drug Regimen [ Time Frame: 12 weeks after the completion of the assigned study drug regimen ] [ Designated as safety issue: No ]
  • Adverse Events and Clinical Laboratory Assessments, Including ALT and Other Liver Function Tests [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Genotypic and Phenotypic Analyses of the NS3•4A HCV Region [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • Pharmacokinetic Assessments of Telaprevir, Peginterferon Alfa-2a, and Ribavirin [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Plasma HCV RNA at other time points
  • Safety assessment
  • Analysis of viral variants
  • VX-950, Peg-IFN-a-2a, and RBV pharmacokinetics
Not Provided
Not Provided
 
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment

Study the effectiveness of VX-950 in combination with Peg-Interferon alpha (Peg-IFN) and Ribavirin (RBV) in reducing plasma HCV RNA levels

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Telaprevir
    tablet
    Other Name: VX-950
  • Drug: Ribavirin
    tablet
    Other Name: RBV
  • Drug: Peginterferon Alfa 2a
    Solution for injection
    Other Name: Peg-IFN
  • Other: Placebo
    matching placebo tablet
  • Placebo Comparator: Pbo12/PR48
    Placebo + Peg-IFN + RBV for 12 weeks, followed by Peg-IFN + RBV for 36 weeks
    Interventions:
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
    • Other: Placebo
  • Experimental: T12/PR48
    Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 36 weeks
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
  • Experimental: T12/PR24
    Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
  • Experimental: T12/PR12
    Telaprevir + Peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Peginterferon Alfa 2a
McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hepatitis C virus Genotype 1 with detectable plasma HCV RNA
  • Have been infected with Hepatitis C virus for >6 months.
  • Seronegative for HbsAg and HIV1 and HIV2
  • 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-a-2a or RBV 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 (NASH) 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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00336479
VX05-950-104
Yes
Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP