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

July 22, 2015 updated by: Janssen-Cilag International NV

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Bedford, Australia
      • Box Hill, Australia
      • Camperdown, Australia
      • Camperdown N/A, Australia
      • Central Queensland M C, Australia
      • Concord, Australia
      • Darlinghurst, Australia
      • Fitzroy, Australia
      • Fremantle, Australia
      • Greenslopes, Australia
      • Heidelberg, Australia
      • Herston, Australia
      • Kingswood, Australia
      • Kogarah, Australia
      • Liverpool, Australia
      • Melbourne, Australia
      • New Lambton Heights, Australia
      • Parkville, Australia
      • Parkville - Vic, Australia
      • Perth, Australia
      • Sydney, Australia
      • Woolloongabba, Australia
  • Austria
      • Graz, Austria
      • Innsbruck, Austria
      • Linz, Austria
      • Wels N/A, Austria
      • Wien, Austria
  • Belgium
      • Antwerpen, Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Genk, Belgium
      • Gent, Belgium
      • Laken (Brussel), Belgium
      • Leuven, Belgium
      • Liège, Belgium
  • Brazil
      • Pinheiros, Brazil
      • Porto Alegre, Brazil
      • Recife, Brazil
      • Rio De Janeiro, Brazil
      • Sao Paulo, Brazil
      • São Paulo, Brazil
  • Czech Republic
      • Hradec Kralove, Czech Republic
      • Opava, Czech Republic
      • Praha 2, Czech Republic
      • Praha 4 N/A, Czech Republic
      • Usti Nad Labem, Czech Republic
  • Germany
      • Berlin, Germany
      • Düsseldorf, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Herne, Germany
      • Koln, Germany
      • Leipzig, Germany
      • München, Germany
      • Münster, Germany
      • Würzburg, Germany
  • Greece
      • Alexandroupolis, Greece
      • Athens, Greece
      • Heraklion Crete, Greece
      • Ioannina, Greece
      • Larisa, Greece
      • Patra, Greece
      • Thessaloniki, Greece
      • Thessalonikis, Greece
  • Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Gyula, Hungary
      • Kaposvár, Hungary
      • Pecs, Hungary
      • Szeged N/A, Hungary
      • Székesfehérvár, Hungary
  • Luxembourg
      • Luxembourg, Luxembourg
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Hamilton, New Zealand
  • Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Constanta, Romania
      • Iasi, Romania
      • Ploiesti, Romania
      • Timisoara, Romania
  • Russian Federation
      • Ekaterinbourg, Russian Federation
      • Moscow, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
      • Stavropol, Russian Federation
      • Tyumen, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Belgrade Serbia, Serbia
      • Nis, Serbia
      • Novi Sad, Serbia
  • Spain
      • A Coruña, Spain
      • Alcorcon, Spain
      • Alicante, Spain
      • Almeria, Spain
      • Avila, Spain
      • Baracaldo, Spain
      • Barcelona, Spain
      • Cordoba, Spain
      • Girona, Spain
      • Granada, Spain
      • La Coruÿa N/A, Spain
      • Leon, Spain
      • Madrid, Spain
      • Majadahonda (Madrid), Spain
      • Malaga, Spain
      • Málaga, Spain
      • Oviedo, Spain
      • Palma De Mallorca, Spain
      • Pamplona, Spain
      • Pontevedra, Spain
      • Sabadell, Spain
      • San Sebastian,, Spain
      • Santa Cruz De Tenerife, Spain
      • Santander, Spain
      • Sevilla, Spain
      • Toledo, Spain
      • Valencia, Spain
      • Zaragoza, Spain
  • Switzerland
      • Basel, Switzerland
      • Basel Bs, Switzerland
      • Bern, Switzerland
      • Geneve 14, Switzerland
      • Lausanne, Switzerland
      • Lugano, Switzerland
      • St Gallen, Switzerland
      • Zürich, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have evidence of hepatitis C virus infection genotype 1 (by molecular assay); - have quantifiable plasma hepatitis C viral RNA levels; - have documented liver fibrosis as assessed by liver biopsy or a non-invasive test showing severe fibrosis or cirrhosis (for subjects with severe fibrosis, the diagnostic test should have been performed within the past 18 months); - have compensated liver disease (Child-Pugh Grade A clinical classification); - have access to hepatitis C treatment (peginterferon-alfa/ribavarin)

Exclusion Criteria:

  • eligible for enrollment into an ongoing clinical study of telaprevir; - infected or co-infected with hepatitis C virus of a genotype other than genotype 1 and/or co-infected with HIV; - contraindication to the administration of peginterferon-alfa or ribavarin, or medical history or laboratory values that preclude treatment with peginterferon-alfa or ribavarin according to the respective local prescribing information; - history of having previously received an investigational treatment with hepatitis C viral protease or polymerase inhibitors (a class of drugs like telaprevir); - signs or symptoms of hepatocellular carcinoma (tests for serum alpha-fetoprotein and ultrasonography should have been done a maximum of 4 months before screening to screen for hepetocellular carcinoma)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag International NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017857
  • VX-950HEP3002 (Other Identifier: Janssen)
  • 2010-023669-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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