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

NCT00420784 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2014-08-05

Study results available
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Summary

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.

Conditions

  • Hepatitis C

Interventions

DRUG

Telaprevir

tablet

DRUG

Ribavirin

tablet

DRUG

Pegylated Interferon Alfa 2a

Solution for injection

DRUG

Matching Placebo

Tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • United States
  • Canada
  • Germany
  • Netherlands
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00420784 on ClinicalTrials.gov