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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014