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
  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:


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

  Hide Study Locations
Locations
United States, Arizona
Call For Information
Phoenix, Arizona, United States
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Liver Research
Palo Alto, California, United States
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San Francisco, California, United States
United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
United States, Florida
Shands Hospital University of Florida
Gainesville, Florida, United States, 32610
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Miami, Florida, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States
United States, Indiana
Clarian Hospital
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Gulf Coast Research Associates
Baton Rouge, Louisiana, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
United States, Minnesota
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Rochester, Minnesota, United States
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States
United States, New York
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Manhasset, New York, United States
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New York, New York, United States
Columbia University Medical Center
New York, New York, United States
United States, North Carolina
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Fox Chase/ Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Methodist Hospital of Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Inova Fairfax Hospital
Annandale, Virginia, United States, 22003
University of Virginia Health System
Charlotteville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States, 22031
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Puerto Rico
Fundacion de Investigacion de Diego
Santurce, Puerto Rico, 00909
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 April 17, 2014