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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:
NCT00262483
First received: December 2, 2005
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

Inclusion Criteria:

  • Infected with hepatitis C virus

Exclusion Criteria:

  • Contraindications to peginterferon or ribavirin therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 2, 2005
Last Updated: December 17, 2007
Health Authority: United States: Food and Drug Administration

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
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 May 19, 2013