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

Phase 2CompletedNCT00420784

Vertex Pharmaceuticals Incorporated465 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

465

Conditions

Hepatitis C

Interventions

TelaprevirDRUG

tablet

RibavirinDRUG

tablet

Pegylated Interferon Alfa 2aDRUG

Solution for injection

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (53)

Outcomes

Primary Outcomes

Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

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).

Time frame: 24 weeks after the completion of study drug dosing (up to Week 72)

Secondary Outcomes

Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing

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).

Time frame: Completion of study drug dosing (up to Week 48)

Percentage of Subjects With Undetectable Plasma HCV RNA

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).

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)

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Data from ClinicalTrials.gov

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Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

USC

Los Angeles, California, United States

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

University of Colorado Health Sciences Center

Denver, Colorado, United States

Unnamed facility

Englewood, Colorado, United States

Unnamed facility

Bardenton, Florida, United States

University of Florida

Gainesville, Florida, United States

...and 43 more locations