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

Sponsor:	Vertex Pharmaceuticals Incorporated
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00420784

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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) 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 C

Drug Information available for: Ribavirin Interferon alfa-2a Peginterferon Alfa-2a Interferon alfa-n1 Telaprevir Interferons

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Undetectable HCV RNA [ Time Frame: at end of treatment ] [ Designated as safety issue: No ]
Undetectable HCV RNA [ Time Frame: 48 weeks after completion of treatment (Groups B, C, and D) ] [ Designated as safety issue: No ]
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: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	440
Study Start Date:	January 2007
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks	Drug: Ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for injection
2: Experimental Telaprevir + Peg-IFN + RBV for 24 weeks followed by Peg-IFN + RBV for 24 weeks	Drug: Telaprevir tablet Drug: Ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for injection
3: Experimental Telaprevir + Peg-IFN for 24 weeks	Drug: Telaprevir tablet Drug: Peg-interferon Alfa-2a Solution for injection
4: Experimental Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks	Drug: Telaprevir tablet 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:

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

Show 53 Study Locations

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:	VX06-950-106
Study First Received:	January 8, 2007
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00420784 History of Changes
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:

Antimetabolites
Anti-Infective Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Ribavirin
Physiological Effects of Drugs
Hepatitis, Viral, Human
Therapeutic Uses
Hepatitis C
Angiogenesis Modulating Agents

Growth Inhibitors
Interferon-alpha
RNA Virus Infections
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Peginterferon alfa-2a
Interferon Alfa-2a

ClinicalTrials.gov processed this record on November 30, 2009