A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma HCV RNA Levels Did Not Respond to Therapy - Full Text View

Purpose

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106, VX05-950-104, and VX05-950-104EU who stopped treatment due to inadequate response to treatment. Safety, tolerability, and HCV RNA levels will be collected.

Condition	Intervention	Phase
Hepatitis C	Drug: telaprevir Drug: ribavirin Drug: Peg-interferon Alfa-2a	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

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

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Proportion of Subjects With Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with SVR24 (undetectable HCV RNA 24 weeks after the completion of treatment)
Adverse Events and Clinical Laboratory Assessments [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
Proportion of subjects with SVR24 (undetectable HCV RNA 24 weeks after the completion of treatment) in prior relapsers
Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with End of Treatment Response (undetectable HCV RNA at end of treatment), overall
Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: 48 weeks after completion of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with SVR48 among Subjects Completing Assigned Treatment, Overall
Cross Tabulation of eRVR and SVR Responses in Study 107 With Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Number of subjects who achieved eRVR and/or SVR24

Enrollment:	117
Study Start Date:	October 2007
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: T12/PR24 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks	Drug: telaprevir tablet Other Name: VX-950 Drug: ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for Injection
Experimental: T12/PR48 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 36 weeks	Drug: telaprevir tablet Other Name: VX-950 Drug: ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for Injection
Experimental: Other Subjects in this arm were receiving Telaprevir + Peg-IFN + RBV for 12 weeks. Subjects with a partial response, viral breakthrough, or relapse in the parent study, and who discontinued treatment before Week 12, were included in the "Other" treatment group.	Drug: telaprevir tablet Other Name: VX-950 Drug: ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for Injection

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Enrolled in the control arm of Study VX06-950-106, VX05-950-104 or VX05-950-104EU

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535847

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Locations

United States, Alabama

Birmingham, Alabama, United States
United States, California

Los Angeles, California, United States
Kaiser Permanente Internal Medicine
San Diego, California, United States

San Francisco, California, United States
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
United States, Florida
University of Florida
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States

Sarasota, Florida, United States
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
United States, Illinois
University of Chicago
Chicago, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Louisiana
Digestive and Liver Disease Clinic
Baton Rouge, Louisiana, United States
United States, Maine
Virology Treatment Center, Maine Medical Center
Portland, Maine, United States
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States
United States, Missouri
St Louis University
St Louis, Missouri, United States
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States
United States, New York
North Shore University Hospital
Manhasset, New York, United States

New York, New York, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States

Cleveland, Ohio, United States
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Columbia Gastroenterology Associates, PA
Columbia, South Carolina, United States
United States, Tennessee
Memphis Gastroenterology Group
Germantown, Tennessee, United States
United States, Texas
Liver Institute at Methodist Dallas
Dallas, Texas, United States

Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
United States, Virginia

Annandale, Virginia, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
McGuire DVAMC
Richmond, Virginia, United States
Austria

Vienna, Austria
Canada, Alberta
University of Calgary Medical Clinic
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
University of British Columbia Vancouver General Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba

Winnipeg, Manitoba, Canada
Canada, Ontario

Toronto, Ontario, Canada
France
Hospital Henri Mondor
Creteil, France

Lyon, France

Nice, France

Paris, France

Pessac, France

Vandoeuvre, France
Germany

Berlin, Germany
Universitatsklinikum Bonn
Bonn, Germany
University of Cologne
Cologne, Germany
Uniklinik Duesseldorf
Dusseldorf, Germany, 40225

Frankfurt, Germany

Hannover, Germany
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus MC Medical Center
Rotterdam, Netherlands
Puerto Rico
Fundacion de Investigation de Diego
Santurce, Puerto Rico
United Kingdom

London, United Kingdom

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Tibotec, Inc

Investigators

Study Director:

Nathalie Adda, MD

Vertex Pharmaceuticals Incorporated

More Information

No publications provided

Responsible Party:	Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00535847 History of Changes
Other Study ID Numbers:	VX06-950-107
Study First Received:	September 25, 2007
Results First Received:	June 22, 2011
Last Updated:	June 22, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vertex Pharmaceuticals Incorporated:

Genotype 1

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
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin

Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013