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

This study has been completed.
Information provided by:
Vertex Pharmaceuticals Incorporated Identifier:
First received: December 2, 2005
Last updated: December 17, 2007
Last verified: December 2007
To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.

Condition Intervention Phase
Hepatitis C
Drug: VX-950
Drug: ribavirin
Drug: peginterferon alfa-2a
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C

Resource links provided by NLM:

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Safety of triple combination therapy. [ Time Frame: retrospective and prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin. [ Time Frame: retrospective and prospective ] [ Designated as safety issue: No ]
  • Plasma HCV RNA levels [ Time Frame: retrospective and prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2005
Study Completion Date: April 2006

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

Inclusion Criteria:

  • Infected with hepatitis C virus

Exclusion Criteria:

  • Contraindications to peginterferon or ribavirin therapy.
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Please refer to this study by its identifier: NCT00262483

United States, Texas
Call for information
San Antonio, Texas, United States
Puerto Rico
Call for information
Santurce, Puerto Rico
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated Identifier: NCT00262483     History of Changes
Other Study ID Numbers: VX05-950-102 
Study First Received: December 2, 2005
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016