A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

July 9, 2014 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

465

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary Medical Clinic - Health Science Centre
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Hepatitis Program
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Toronto, Ontario, Canada
      • Toronto, Ontario, Canada
        • Toronto Western Hospital
  • Germany
      • Berlin, Germany
        • Universitätsmedizin Berlin
      • Frankfurt, Germany
        • University Clinic Frankfurt, Department of Internal Medicine
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Rotterdam, Netherlands
        • Erasmus MC University Medical Center
  • Puerto Rico
      • Santurce, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Birmingham Gastroenterology Associates
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States
        • USC
      • San Diego, California, United States
        • University of California, San Diego
      • San Diego, California, United States
        • Kaiser Permanente Hepatology Research
      • San Francisco, California, United States
        • University of California San Francisco
    • Colorado
      • Denver, Colorado, United States
        • University of Colorado Health Sciences Center
      • Englewood, Colorado, United States
    • Florida
      • Bardenton, Florida, United States
      • Gainesville, Florida, United States
        • University of Florida
      • Jacksonville, Florida, United States
        • Borland-Groover Clinic
      • Jacksonville, Florida, United States
        • Mayo Clinic Jacksonville
      • Miami, Florida, United States
      • Sarasota, Florida, United States
        • University Hepatitis Center at Bach & Godofsky
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Gulf Coast Research, LLC
    • Maine
      • Portland, Maine, United States
        • Virology Treatment Center, Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States
        • Beth Isreal Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital
    • Missouri
      • St Louis, Missouri, United States
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Manhasset, New York, United States
        • North Shore University Hospital
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
        • University Internal Medicine Associates, Inc.
      • Cleveland, Ohio, United States
        • Cleveland Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
        • Columbia Gastroenterology Associates, PA
    • Tennessee
      • Germantown, Tennessee, United States
        • Memphis Gastroenterology Group
    • Texas
      • Dallas, Texas, United States
        • Liver Institute at Methodist Dallas
      • Houston, Texas, United States
        • Advanced Liver Therapies
      • San Antonio, Texas, United States
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, United States
      • Fairfax, Virginia, United States
        • Metropolitan Research
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females between 18 and 70 years old
  • Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
  • Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
  • Cannot also be infected with Human Immunodeficiency Virus 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 cannot 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
Drug: Ribavirin
tablet
Other Names:
  • RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Names:
  • Peg-IFN-alfa-2a
Drug: Telaprevir
tablet
Other Names:
  • VX-950
Experimental: Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Drug: Ribavirin
tablet
Other Names:
  • RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Names:
  • Peg-IFN-alfa-2a
Drug: Telaprevir
tablet
Other Names:
  • VX-950
Experimental: Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Names:
  • Peg-IFN-alfa-2a
Drug: Telaprevir
tablet
Other Names:
  • VX-950
Placebo Comparator: PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
Drug: Ribavirin
tablet
Other Names:
  • RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Names:
  • Peg-IFN-alfa-2a
Drug: Matching Placebo
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
Time Frame: 24 weeks after the completion of study drug dosing (up to Week 72)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
24 weeks after the completion of study drug dosing (up to Week 72)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
Time Frame: Completion of study drug dosing (up to Week 48)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Completion of study drug dosing (up to Week 48)
Percentage of Subjects With Undetectable Plasma HCV RNA
Time Frame: Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 2 weeks after last dose of study drug (up to Week 50)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline up to 2 weeks after last dose of study drug (up to Week 50)
Number of Subjects With Viral Relapse
Time Frame: After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Time Frame: Week 2, 4, 8, 12, 16, 24
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Week 2, 4, 8, 12, 16, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 8, 2007

First Submitted That Met QC Criteria

January 8, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX06-950-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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