A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C - Full Text View

Purpose

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with peginterferon alfa-2a (Pegasys®), and ribavirin (Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Condition	Intervention	Phase
Hepatitis C	Drug: Telaprevir Drug: Ribavirin Drug: Peg-interferon Alfa-2a Drug: Matching Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2 Study of Telaprevir in Combination With Peginterferon Alfa-2a, and Ribavirin in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy

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:

Undetectable HCV RNA at 24 Weeks After the Completion of Treatment [ Time Frame: 24 weeks after the end of treatment (after actual last dose) ] [ Designated as safety issue: No ]
The primary efficacy variable was the proportion of subjects with SVR, i.e., subjects with undetectable HCV RNA 24 weeks after the end of treatment (after actual last dose).

Secondary Outcome Measures:

Undetectable HCV RNA [ Time Frame: at the completion of treatment ] [ Designated as safety issue: No ]
Proportion of subjects with an end of treatment response [undetectable HCV RNA at end of treatment])
Undetectable HCV RNA [ Time Frame: 48 weeks after completion of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with Undetectable HCV RNA at 24 Weeks AVFU for Treatment Groups Pbo/PR48,and at 48 Weeks AVFU for Treatment Groups T12/PR24, T24/PR48 and T24/P24
Adverse Events and Clinical Laboratory Assessments, Including ALT and Other Liver Function Tests. [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Genotypic and Phenotypic Analyses of the NS3•4A HCV Region. [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Pharmacokinetic Assessments of Telaprevir, Peg-IFN-a-2a, and RBV. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	465
Study Start Date:	February 2007
Study Completion Date:	April 2009
Primary Completion Date:	December 2008 (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 Other Name: RBV Drug: Peg-interferon Alfa-2a Solution for injection Other Name: Peg-IFN
Experimental: T24/PR48 Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks	Drug: Telaprevir tablet Other Name: VX-950 Drug: Ribavirin tablet Other Name: RBV Drug: Peg-interferon Alfa-2a Solution for injection Other Name: Peg-IFN
Experimental: T24/P24 Telaprevir + Peg-IFN for 24 weeks	Drug: Telaprevir tablet Other Name: VX-950 Drug: Peg-interferon Alfa-2a Solution for injection Other Name: Peg-IFN
Placebo Comparator: Pbo24/PR48 Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks	Drug: Ribavirin tablet Other Name: RBV Drug: Peg-interferon Alfa-2a Solution for injection Other Name: Peg-IFN Drug: Matching Placebo Tablet

Eligibility

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

Criteria

Inclusion Criteria:

Males and females between 18 and 70 years old
Detectable plasma HCV RNA > or = 10,000 IU/mL
Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of peginterferon with ribavirin
Can not also be infected with HIV (AIDS) or hepatitis B
Must be judged to be in general good health and able to receive Pegasys® and Copegus®.
No drug or alcohol abuse in the last year
Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
If you are a woman, you can not be in this study if you are pregnant or nursing.

Exclusion Criteria:

Participation in any clinical trial of a HCV protease inhibitor of any duration.
Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis.
Diagnosed or suspected hepatocellular carcinoma.
History of or current evidence of decompensated liver disease.
Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420784

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Locations

United States, Alabama
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States
United States, California
USC
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Hepatology Research
San Diego, California, United States
University of California, San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States

Englewood, Colorado, United States
United States, Florida

Bardenton, Florida, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States

Miami, Florida, United States
University Hepatitis Center at Bach & Godofsky
Sarasota, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Louisiana
Gulf Coast Research, LLC
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 Isreal Deaconess Medical Center
Boston, Massachusetts, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States
United States, Missouri
Saint Louis University
St Louis, Missouri, United States
United States, Nebraska

Omaha, Nebraska, United States
United States, 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

Durham, North Carolina, United States
United States, Ohio
University Internal Medicine Associates, Inc.
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
United States, Pennsylvania

Hershey, Pennsylvania, United States

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
Advanced Liver Therapies
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
United States, Virginia

Annandale, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States

Richmond, Virginia, United States
United States, Washington

Seattle, Washington, United States
Canada, Alberta
University of Calgary Medical Clinic - Health Science Centre
Calgary, Alberta, Canada, T2N 4N1

Edmonton, Alberta, Canada
Canada, British Columbia
BC Hepatitis Program
Vancouver, British Columbia, Canada
Canada, Manitoba

Winnipeg, Manitoba, Canada
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada

Toronto, Ontario, Canada
Germany
Universitatsmedizin Berlin
Berlin, Germany
University Clinic Frankfurt, Department of Internal Medicine
Frankfurt, Germany
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus MC University Medical Center
Rotterdam, Netherlands
Puerto Rico

Santurce, Puerto Rico

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

Study Director:

Medical Monitor

Vertex Pharmaceuticals Incorporated

More Information

No publications provided by Vertex Pharmaceuticals Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li S, Zhu J, Zhang W, Chen Y, Zhang K, Popescu LM, Ma X, Lau WB, Rong R, Yu X, Wang B, Li Y, Xiao C, Zhang M, Wang S, Yu L, Chen AF, Yang X, Cai J. Signature microRNA expression profile of essential hypertension and its novel link to human cytomegalovirus infection. Circulation. 2011 Jul 12;124(2):175-84. Epub 2011 Jun 20.

McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, Heathcote EJ, Zeuzem S, Reesink HW, Garg J, Bsharat M, George S, Kauffman RS, Adda N, Di Bisceglie AM; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010 Apr 8;362(14):1292-303.

Responsible Party:	Robert Kauffman M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00420784 History of Changes
Other Study ID Numbers:	VX06-950-106
Study First Received:	January 8, 2007
Results First Received:	June 22, 2011
Last Updated:	June 22, 2011
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Canada: Health Canada Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 May 16, 2013