Clinical trial NCT01508286: Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
Official title: 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Hepatitis C
Keywords: telaprevir
hepatitis C
early access program
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2012-01-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Bedford
country: Australia
city: Box Hill
country: Australia
city: Camperdown N/A
country: Australia
city: Camperdown
country: Australia
city: Central Queensland M C
country: Australia
city: Concord
country: Australia
city: Darlinghurst
country: Australia
city: Fitzroy
country: Australia
city: Fremantle
country: Australia
city: Greenslopes
country: Australia
city: Heidelberg
country: Australia
city: Herston
country: Australia
city: Kingswood
country: Australia
city: Kogarah
country: Australia
city: Liverpool
country: Australia
city: Melbourne
country: Australia
city: New Lambton Heights
country: Australia
city: Parkville - Vic
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Woolloongabba
country: Australia
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Wels N/A
country: Austria
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Laken (Brussel)
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Pinheiros
country: Brazil
city: Porto Alegre
country: Brazil
city: Recife
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: São Paulo
country: Brazil
city: Hradec Kralove
country: Czech Republic
city: Opava
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 4 N/A
country: Czech Republic
city: Usti Nad Labem
country: Czech Republic
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Essen
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Herne
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Würzburg
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Heraklion Crete
country: Greece
city: Ioannina
country: Greece
city: Larisa
country: Greece
city: Patra
country: Greece
city: Thessalonikis
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Kaposvár
country: Hungary
city: Pecs
country: Hungary
city: Szeged N/A
country: Hungary
city: Székesfehérvár
country: Hungary
city: Luxembourg
country: Luxembourg
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Hamilton
country: New Zealand
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Ploiesti
country: Romania
city: Timisoara
country: Romania
city: Ekaterinbourg
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tyumen
country: Russian Federation
city: Belgrade Serbia
country: Serbia
city: Belgrade
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: A Coruña
country: Spain
city: Alcorcon
country: Spain
city: Alicante
country: Spain
city: Almeria
country: Spain
city: Avila
country: Spain
city: Baracaldo
country: Spain
city: Barcelona
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: La Coruÿa N/A
country: Spain
city: Leon
country: Spain
city: Madrid
country: Spain
city: Majadahonda (Madrid)
country: Spain
city: Malaga
country: Spain
city: Málaga
country: Spain
city: Oviedo
country: Spain
city: Palma De Mallorca
country: Spain
city: Pamplona
country: Spain
city: Pontevedra
country: Spain
city: Sabadell
country: Spain
city: San Sebastian,
country: Spain
city: Santa Cruz De Tenerife
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Basel Bs
country: Switzerland
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Geneve 14
country: Switzerland
city: Lausanne
country: Switzerland
city: Lugano
country: Switzerland
city: St Gallen
country: Switzerland
city: Zürich
country: Switzerland
Study officials:
References:
citation: Lepida A, Colombo M, Fernandez I, Abdurakhmanov D, Ferreira PA, Strasser SI, Urbanek P, Mangia A, Calleja JL, Iraqi W, DeMasi R, Lonjon-Domanec I, Moreno C, Wedemeyer H. Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis. PLoS One. 2015 Sep 23;10(9):e0138503. doi: 10.1371/journal.pone.0138503. eCollection 2015.