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

Sponsoren

Hauptsponsor: Janssen-Cilag International NV

Quelle Janssen-Cilag International NV
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus No longer available
Studientyp Expanded Access
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Telaprevir + peginterferon alfa + ribavirin

Beschreibung: 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.

Anderer Name: experimental

Interventionsart: Drug

Interventionsname: peginterferon alfa + ribavirin

Beschreibung: 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.

Anderer Name: experimental

Interventionsart: Drug

Interventionsname: peginterferon alfa + ribavirin

Beschreibung: 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.

Anderer Name: experimental

Teilnahmeberechtigung

Kriterien:

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)

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Ort
Einrichtung:
| Adelaide, Australia
| Bedford, Australia
| Box Hill, Australia
| Camperdown N/A, Australia
| Camperdown, 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 - Vic, Australia
| Parkville, Australia
| Perth, Australia
| Sydney, Australia
| Woolloongabba, Australia
| Graz, Austria
| Innsbruck, Austria
| Linz, Austria
| Wels N/A, Austria
| Wien, Austria
| Antwerpen, Belgium
| Brugge, Belgium
| Brussels, Belgium
| Bruxelles, Belgium
| Edegem, Belgium
| Genk, Belgium
| Gent, Belgium
| Laken (Brussel), Belgium
| Leuven, Belgium
| Liège, Belgium
| Pinheiros, Brazil
| Porto Alegre, Brazil
| Recife, Brazil
| Rio De Janeiro, Brazil
| Sao Paulo, Brazil
| São Paulo, Brazil
| Hradec Kralove, Czech Republic
| Opava, Czech Republic
| Praha 2, Czech Republic
| Praha 4 N/A, Czech Republic
| Usti Nad Labem, Czech Republic
| 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
| Alexandroupolis, Greece
| Athens, Greece
| Heraklion Crete, Greece
| Ioannina, Greece
| Larisa, Greece
| Patra, Greece
| Thessalonikis, Greece
| Thessaloniki, Greece
| Budapest, Hungary
| Debrecen, Hungary
| Gyula, Hungary
| Kaposvár, Hungary
| Pecs, Hungary
| Szeged N/A, Hungary
| Székesfehérvár, Hungary
| Luxembourg, Luxembourg
| Auckland, New Zealand
| Christchurch, New Zealand
| Hamilton, New Zealand
| Bucharest, Romania
| Bucuresti, Romania
| Constanta, Romania
| Iasi, Romania
| Ploiesti, Romania
| Timisoara, Romania
| Ekaterinbourg, Russian Federation
| Moscow, Russian Federation
| Saint Petersburg, Russian Federation
| Saint-Petersburg, Russian Federation
| Samara, Russian Federation
| Stavropol, Russian Federation
| Tyumen, Russian Federation
| Belgrade Serbia, Serbia
| Belgrade, Serbia
| Nis, Serbia
| Novi Sad, Serbia
| 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
| Basel Bs, Switzerland
| Basel, Switzerland
| Bern, Switzerland
| Geneve 14, Switzerland
| Lausanne, Switzerland
| Lugano, Switzerland
| St Gallen, Switzerland
| Zürich, Switzerland
Standort Länder

Australia

Austria

Belgium

Brazil

Czech Republic

Germany

Greece

Hungary

Luxembourg

New Zealand

Romania

Russian Federation

Serbia

Spain

Switzerland

Überprüfungsdatum

July 2015

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Quelle: ClinicalTrials.gov