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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
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
 Drug: Telaprevir
Drug: Ribavirin
Drug: Peginterferon Alfa 2a
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 263
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pbo12/PR48
Placebo + Peg-IFN + RBV for 12 weeks, followed by Peg-IFN + RBV for 36 weeks
 Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Other: Placebo
matching placebo tablet
Experimental: T12/PR48
Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 36 weeks
 Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Experimental: T12/PR24
Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 12 weeks
 Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Experimental: T12/PR12
Telaprevir + Peg-IFN + RBV for 12 weeks
 Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336479

  Show 37 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided by Vertex Pharmaceuticals Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00336479     History of Changes
Other Study ID Numbers: VX05-950-104
Study First Received: June 9, 2006
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013