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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262483
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 21, 2007
Information provided by:
Vertex Pharmaceuticals Incorporated

Brief Summary:
To assess the safety of the combination of VX-950, Pegasys and Copegus in subjects with hepatitis C.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: VX-950 Drug: ribavirin Drug: peginterferon alfa-2a Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Safety of triple combination therapy. [ Time Frame: retrospective and prospective ]

Secondary Outcome Measures :
  1. Pharmacokinetics of VX-950, peginterferon alfa-2a and ribavirin. [ Time Frame: retrospective and prospective ]
  2. Plasma HCV RNA levels [ Time Frame: retrospective and prospective ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infected with hepatitis C virus

Exclusion Criteria:

  • Contraindications to peginterferon or ribavirin therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262483

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

Responsible Party: Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated Identifier: NCT00262483     History of Changes
Other Study ID Numbers: VX05-950-102
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

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