NCT01508286

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

Multicenter, Open-label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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.

Detailed description

This is a multicenter, multinational, open-label, non-comparative early access program designed to provide telaprevir to patients infected with hepatitis C virus genotype 1, who have a documented diagnosis of liver fibrosis and compensated liver disease (Child Pugh Grade A), and are expected to benefit from telaprevir-based therapy. Patients will be excluded if they are eligible for enrollment into an ongoing clinical study of telaprevir. Enrollment of patients into this study will continue until telaprevir becomes available for reimbursement in the country in which a patient resides or until September 2013, whichever occurs first, unless otherwise indicated per local regulations. During the first 12 weeks of the study, all patients will receive telaprevir administered orally with food every 8 hours in combination with peginterferon-alfa/ribavirin \[PEG-IFN-alfa/RBV\]). Patients will then be treated with Peg-IFN-alfa/RBV alone for an additional 12 or 36 weeks, based on how they respond to treatment (assessed by levels of hepatitis C viral RNA in the plasma, which reflects the number of virus particles in the bloodstream) and/or by type of patient (patients with severe fibrosis who had not received prior treatment or had previously relapsed during treatment, patients with prior partial or null response \[who had only partially or had not responded to previous treatment\], patients who had viral breakthrough \[recurrence of viral copies during antiviral treatment\], or patients with cirrhosis). For all patients, rules will be applied to ensure that telaprevir or Peg-IFN-alfa/RBV are stopped if subjects have viral breakthrough or treatment failure. All patients should have a follow up visit (including measurement of hepatitis C viral RNA levels in the bloodstream) 24 weeks after the last administered dose of any treatment. Dose modifications of telaprevir are prohibited and once telaprevir treatment is discontinued it may not be reinitiated in this study.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2012-01-11
• Last updated: 2015-07-24

Locations

128 sites across 15 countries: Australia, Austria, Belgium, Brazil, Czechia, Germany, Greece, Hungary, Luxembourg, New Zealand, Romania, Russia, Serbia, Spain, Switzerland