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Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

NCT01508286 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2015-07-24

No results posted yet for this study

Summary

The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.

Conditions

  • Hepatitis C

Interventions

DRUG

Telaprevir + peginterferon alfa + ribavirin

During the first 12 weeks of the early access program, all eligible patients will receive telaprevir 750 mg every 8 hours in combination with peginterferon-alfa and ribavirin.

DRUG

peginterferon alfa + ribavirin

Patients with severe fibrosis who are treatment naïve or prior treatment relapsers will subsequently be treated with peginterferon-alfa and ribavirin alone for either an additional 12 or 36 weeks.

DRUG

peginterferon alfa + ribavirin

Previously treated patients with prior partial or null response, or who had viral breakthrough, with severe fibrosis and all subjects with cirrhosis will subsequently be treated with peginterferon-alfa and ribavirin alone for an additional 36 weeks.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Countries

  • Australia
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Luxembourg
  • New Zealand
  • Romania
  • Russia
  • Serbia
  • Spain
  • Switzerland

Study Locations

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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 NCT01508286 on ClinicalTrials.gov