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

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ClinicalTrials.gov Identifier: NCT00262483
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 21, 2007
Sponsor:
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00262483


Locations
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
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated

Responsible Party: Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov 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
Hepatitis A
Hepatitis C
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs