Hepatitis CNCT01508286
Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
A study testing Telaprevir + peginterferon alfa + ribavirin and peginterferon alfa + ribavirin in people with Hepatitis C, run by Janssen-Cilag International NV at 128 sites in 15 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Telaprevir + peginterferon alfa + ribavirin and peginterferon alfa + ribavirin
- How many people
- Not given
- Where
- 128 sitesin 15 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
128 sites in 15 countries.
128 sites in 15 countries
Spain27 sites
Study site
A Coruña
Study site
Alcorcón
Study site
Alicante
Study site
Almería
Study site
Ávila
Study site
Barakaldo
Study site
Barcelona
Study site
Córdoba
Study site
Donostia / San Sebastian
Study site
Girona
Study site
Granada
Study site
La Coruÿa N/A
Study site
León
Study site
Madrid
Study site
Majadahonda (Madrid)
Study site
Málaga
Study site
Oviedo
Study site
Palma de Mallorca
Study site
Pamplona
Study site
Pontevedra
Study site
Sabadell
Study site
Santa Cruz de Tenerife
Study site
Santander
Study site
Seville
Study site
Toledo
Study site
Valencia
Study site
Zaragoza
Australia22 sites
Study site
Adelaide
Study site
Bedford
Study site
Box Hill
Study site
Camperdown
Study site
Central Queensland M C
Study site
Concord
Study site
Darlinghurst
Study site
Fitzroy
Study site
Fremantle
Study site
Greenslopes
Study site
Heidelberg
Study site
Herston
Study site
Kingswood
Study site
Kogarah
Study site
Liverpool
Study site
Melbourne
Study site
New Lambton Heights
Study site
Parkville
Study site
Parkville - Vic
Study site
Perth
Study site
Sydney
Study site
Woolloongabba
Germany13 sites
Study site
Berlin
Study site
Cologne
Study site
Düsseldorf
Study site
Essen
Study site
Frankfurt
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Hanover
Study site
Herne
Study site
Leipzig
Study site
München
Study site
Münster
Study site
Würzburg
Belgium9 sites
Study site
Antwerp
Study site
Bruges
Study site
Brussels
Study site
Edegem
Study site
Genk
Study site
Ghent
Study site
Laken (Brussel)
Study site
Leuven
Study site
Liège
Greece8 sites
Study site
Alexandroupoli
Study site
Athens
Study site
Heraklion Crete
Study site
Ioannina
Study site
Larissa
Study site
Pátrai
Study site
Thessaloniki
Study site
Thessalonikis
Switzerland8 sites
Study site
Basel
Study site
Basel Bs
Study site
Bern
Study site
Geneva
Study site
Lausanne
Study site
Lugano
Study site
Sankt Gallen
Study site
Zurich
Hungary7 sites
Study site
Budapest
Study site
Debrecen
Study site
Gyula
Study site
Kaposvár
Study site
Pécs
Study site
Szeged
Study site
Székesfehérvár
Russia6 sites
Study site
Moscow
Study site
Saint Petersburg
Study site
Samara
Study site
Stavropol
Study site
Tyumen
Study site
Yekaterinburg
Austria5 sites
Study site
Graz
Study site
Innsbruck
Study site
Linz
Study site
Vienna
Study site
Wels
Brazil5 sites
Study site
Pinheiros
Study site
Porto Alegre
Study site
Recife
Study site
Rio de Janeiro
Study site
São Paulo
Czechia5 sites
Study site
Hradec Králové
Study site
Opava
Study site
Prague
Study site
Praha 4 N/A
Study site
Ústí nad Labem
Romania5 sites
Study site
Bucharest
Study site
Constanța
Study site
Iași
Study site
Ploieşti
Study site
Timișoara
Serbia4 sites
Study site
Belgrade
Study site
Belgrade Serbia
Study site
Niš
Study site
Novi Sad
New Zealand3 sites
Study site
Auckland
Study site
Christchurch
Study site
Hamilton
About this study
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
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.
Read the 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
- Being tested
- Telaprevir + peginterferon alfa + ribavirin, peginterferon alfa + ribavirin
- Keywords
- telaprevir, hepatitis C, early access program
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telaprevir + peginterferon alfa + ribavirinDrug
Also called experimental
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.
peginterferon alfa + ribavirinDrug
Also called experimental
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.
peginterferon alfa + ribavirinDrug
Also called experimental
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
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508286
- Sponsor's protocol ID
- CR017857
- Other IDs
- VX-950HEP3002, 2010-023669-23
- Status last verified
- Jul 2015
- First submitted
- 9 Jan 2012
- Last updated
- 24 Jul 2015
- Results posted
- No
Publications
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.
PubMed 26398503
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01508286
- Acronym / sponsor ID
- CR017857
- Conditions
- Hepatitis C
- Keywords
- telaprevir, hepatitis C, early access program
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telaprevir + peginterferon alfa + ribavirinAlso: experimentalDuring 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 + ribavirinAlso: experimentalPatients 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 + ribavirinAlso: experimentalPreviously 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Derived from this study: PubMed 26398503Lepida 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.
- 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 CirrhosisLink provided by the sponsor.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
128 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telaprevir + peginterferon alfa + ribavirin and peginterferon alfa + ribavirin in people with Hepatitis C, run by Janssen-Cilag International NV at 128 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 128 sites in Spain, Australia, Germany, Belgium, Greece and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.