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

This study has been completed.

First Received: December 2, 2005 Last Updated: December 17, 2007 History of Changes

Sponsored by:	Vertex Pharmaceuticals Incorporated
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00262483

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 II

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Telaprevir

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

Study placed in the following topic categories:

Interferon-alpha
Antimetabolites
Anti-Infective Agents
Liver Diseases
Ribavirin
Interferons
Hepatitis, Viral, Human
Angiogenesis Inhibitors

Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Ribavirin
Hepatitis, Viral, Human
Angiogenesis Inhibitors

Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Peginterferon alfa-2a
Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Interferon Alfa-2a

ClinicalTrials.gov processed this record on August 30, 2009