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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00372385
First received: September 1, 2006
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

Compare the effectiveness of VX-950 in combination with Peg-Interferon alpha (Peg-IFN) with and without Ribavirin (RBV) in reducing plasma HCV RNA levels.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Ribavirin
Drug: Peginterferon Alfa 2a
Drug: Placebo
Drug: Telaprevir
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 and Without Ribavirin (Copegus®) in Subjects With Hepatitis C

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 the assigned study drug regimen ] [ 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 ]
  • Proportion of Subjects in Each of the Dose Groups B, C and D Who Received VX-950 With Undetectable Plasma HCV RNA at the Completion of the Study Drug Regimen [ Time Frame: Week 12, Week 24, Week 48 ] [ 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 72 ] [ Designated as safety issue: No ]
  • Pharmacokinetic Assessments of Telaprevir, Peginterferon Alfa-2a, and Ribavirin [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 334
Study Start Date: August 2006
Study Completion Date: June 2008
Primary Completion Date: May 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 and RBV for 36 weeks
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Drug: Placebo
tablet
Experimental: T12/PR24
Telaprevir + Peg-IFN + RBV for 12 weeks followed by Peg-IFN + RBV for 12 weeks
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Drug: Telaprevir
tablet
Other Name: VX-950
Experimental: T12/PR12
Telaprevir + Peg-IFN + RBV for 12 weeks
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Drug: Telaprevir
tablet
Other Name: VX-950
Experimental: T12/P12
Telaprevir + Peg-IFN for 12 weeks
Drug: Peginterferon Alfa 2a
Solution for injection
Other Name: Peg-IFN
Drug: Telaprevir
tablet
Other Name: VX-950

  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/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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372385

Locations
Austria
Call For Information
Call For Information, Austria
France
Call For Information
Call For Information, France
Germany
Call For Information
Call For Information, Germany
United Kingdom
Call for Information
Call for Information, United Kingdom
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: NCT00372385     History of Changes
Other Study ID Numbers: VX05-950-104EU
Study First Received: September 1, 2006
Results First Received: June 22, 2011
Last Updated: June 22, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria: Agency for Health and Food Safety
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 21, 2014