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A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

NCT00703118 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2014-01-22

Study results available
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Summary

The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Telaprevir

Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

DRUG

Peg-IFN-alfa-2a

Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

DRUG

Ribavirin

Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

DRUG

Placebo

Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.

Sponsors & Collaborators

  • Tibotec Pharmaceutical Limited

    collaborator INDUSTRY

  • Tibotec BVBA

    lead INDUSTRY

Principal Investigators

  • Tibotec-Virco Virology BVBA Clinical Trial · Tibotec BVBA

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
2008-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Puerto Rico
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs

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 NCT00703118 on ClinicalTrials.gov