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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01508286




Registration number
NCT01508286
Ethics application status
Date submitted
9/01/2012
Date registered
11/01/2012
Date last updated
24/07/2015

Titles & IDs
Public title
Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects
Scientific 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
Secondary ID [1] 0 0
VX-950HEP3002
Secondary ID [2] 0 0
CR017857
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Telaprevir + peginterferon alfa + ribavirin
Treatment: Drugs - peginterferon alfa + ribavirin
Treatment: Drugs - peginterferon alfa + ribavirin

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
NO_LONGER_AVAILABLE
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bedford
Recruitment hospital [3] 0 0
- Box Hill
Recruitment hospital [4] 0 0
- Camperdown N/A
Recruitment hospital [5] 0 0
- Camperdown
Recruitment hospital [6] 0 0
- Central Queensland M C
Recruitment hospital [7] 0 0
- Concord
Recruitment hospital [8] 0 0
- Darlinghurst
Recruitment hospital [9] 0 0
- Fitzroy
Recruitment hospital [10] 0 0
- Fremantle
Recruitment hospital [11] 0 0
- Greenslopes
Recruitment hospital [12] 0 0
- Heidelberg
Recruitment hospital [13] 0 0
- Herston
Recruitment hospital [14] 0 0
- Kingswood
Recruitment hospital [15] 0 0
- Kogarah
Recruitment hospital [16] 0 0
- Liverpool
Recruitment hospital [17] 0 0
- Melbourne
Recruitment hospital [18] 0 0
- New Lambton Heights
Recruitment hospital [19] 0 0
- Parkville - Vic
Recruitment hospital [20] 0 0
- Parkville
Recruitment hospital [21] 0 0
- Perth
Recruitment hospital [22] 0 0
- Sydney
Recruitment hospital [23] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bedford
Recruitment postcode(s) [3] 0 0
- Box Hill
Recruitment postcode(s) [4] 0 0
- Camperdown N/A
Recruitment postcode(s) [5] 0 0
- Camperdown
Recruitment postcode(s) [6] 0 0
- Central Queensland M C
Recruitment postcode(s) [7] 0 0
- Concord
Recruitment postcode(s) [8] 0 0
- Darlinghurst
Recruitment postcode(s) [9] 0 0
- Fitzroy
Recruitment postcode(s) [10] 0 0
- Fremantle
Recruitment postcode(s) [11] 0 0
- Greenslopes
Recruitment postcode(s) [12] 0 0
- Heidelberg
Recruitment postcode(s) [13] 0 0
- Herston
Recruitment postcode(s) [14] 0 0
- Kingswood
Recruitment postcode(s) [15] 0 0
- Kogarah
Recruitment postcode(s) [16] 0 0
- Liverpool
Recruitment postcode(s) [17] 0 0
- Melbourne
Recruitment postcode(s) [18] 0 0
- New Lambton Heights
Recruitment postcode(s) [19] 0 0
- Parkville - Vic
Recruitment postcode(s) [20] 0 0
- Parkville
Recruitment postcode(s) [21] 0 0
- Perth
Recruitment postcode(s) [22] 0 0
- Sydney
Recruitment postcode(s) [23] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Wels N/A
Country [5] 0 0
Austria
State/province [5] 0 0
Wien
Country [6] 0 0
Belgium
State/province [6] 0 0
Antwerpen
Country [7] 0 0
Belgium
State/province [7] 0 0
Brugge
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Edegem
Country [11] 0 0
Belgium
State/province [11] 0 0
Genk
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Laken (Brussel)
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liège
Country [16] 0 0
Brazil
State/province [16] 0 0
Pinheiros
Country [17] 0 0
Brazil
State/province [17] 0 0
Porto Alegre
Country [18] 0 0
Brazil
State/province [18] 0 0
Recife
Country [19] 0 0
Brazil
State/province [19] 0 0
Rio De Janeiro
Country [20] 0 0
Brazil
State/province [20] 0 0
Sao Paulo
Country [21] 0 0
Brazil
State/province [21] 0 0
São Paulo
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Hradec Kralove
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Opava
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Praha 2
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Praha 4 N/A
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Usti Nad Labem
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Düsseldorf
Country [29] 0 0
Germany
State/province [29] 0 0
Essen
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt
Country [31] 0 0
Germany
State/province [31] 0 0
Freiburg
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Germany
State/province [33] 0 0
Hannover
Country [34] 0 0
Germany
State/province [34] 0 0
Herne
Country [35] 0 0
Germany
State/province [35] 0 0
Koln
Country [36] 0 0
Germany
State/province [36] 0 0
Leipzig
Country [37] 0 0
Germany
State/province [37] 0 0
München
Country [38] 0 0
Germany
State/province [38] 0 0
Münster
Country [39] 0 0
Germany
State/province [39] 0 0
Würzburg
Country [40] 0 0
Greece
State/province [40] 0 0
Alexandroupolis
Country [41] 0 0
Greece
State/province [41] 0 0
Athens
Country [42] 0 0
Greece
State/province [42] 0 0
Heraklion Crete
Country [43] 0 0
Greece
State/province [43] 0 0
Ioannina
Country [44] 0 0
Greece
State/province [44] 0 0
Larisa
Country [45] 0 0
Greece
State/province [45] 0 0
Patra
Country [46] 0 0
Greece
State/province [46] 0 0
Thessalonikis
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Debrecen
Country [50] 0 0
Hungary
State/province [50] 0 0
Gyula
Country [51] 0 0
Hungary
State/province [51] 0 0
Kaposvár
Country [52] 0 0
Hungary
State/province [52] 0 0
Pecs
Country [53] 0 0
Hungary
State/province [53] 0 0
Szeged N/A
Country [54] 0 0
Hungary
State/province [54] 0 0
Székesfehérvár
Country [55] 0 0
Luxembourg
State/province [55] 0 0
Luxembourg
Country [56] 0 0
New Zealand
State/province [56] 0 0
Auckland
Country [57] 0 0
New Zealand
State/province [57] 0 0
Christchurch
Country [58] 0 0
New Zealand
State/province [58] 0 0
Hamilton
Country [59] 0 0
Romania
State/province [59] 0 0
Bucharest
Country [60] 0 0
Romania
State/province [60] 0 0
Bucuresti
Country [61] 0 0
Romania
State/province [61] 0 0
Constanta
Country [62] 0 0
Romania
State/province [62] 0 0
Iasi
Country [63] 0 0
Romania
State/province [63] 0 0
Ploiesti
Country [64] 0 0
Romania
State/province [64] 0 0
Timisoara
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Ekaterinbourg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Saint Petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Saint-Petersburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Samara
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Stavropol
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Tyumen
Country [72] 0 0
Serbia
State/province [72] 0 0
Belgrade Serbia
Country [73] 0 0
Serbia
State/province [73] 0 0
Belgrade
Country [74] 0 0
Serbia
State/province [74] 0 0
Nis
Country [75] 0 0
Serbia
State/province [75] 0 0
Novi Sad
Country [76] 0 0
Spain
State/province [76] 0 0
A Coruña
Country [77] 0 0
Spain
State/province [77] 0 0
Alcorcon
Country [78] 0 0
Spain
State/province [78] 0 0
Alicante
Country [79] 0 0
Spain
State/province [79] 0 0
Almeria
Country [80] 0 0
Spain
State/province [80] 0 0
Avila
Country [81] 0 0
Spain
State/province [81] 0 0
Baracaldo
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Cordoba
Country [84] 0 0
Spain
State/province [84] 0 0
Girona
Country [85] 0 0
Spain
State/province [85] 0 0
Granada
Country [86] 0 0
Spain
State/province [86] 0 0
La Coruÿa N/A
Country [87] 0 0
Spain
State/province [87] 0 0
Leon
Country [88] 0 0
Spain
State/province [88] 0 0
Madrid
Country [89] 0 0
Spain
State/province [89] 0 0
Majadahonda (Madrid)
Country [90] 0 0
Spain
State/province [90] 0 0
Malaga
Country [91] 0 0
Spain
State/province [91] 0 0
Málaga
Country [92] 0 0
Spain
State/province [92] 0 0
Oviedo
Country [93] 0 0
Spain
State/province [93] 0 0
Palma De Mallorca
Country [94] 0 0
Spain
State/province [94] 0 0
Pamplona
Country [95] 0 0
Spain
State/province [95] 0 0
Pontevedra
Country [96] 0 0
Spain
State/province [96] 0 0
Sabadell
Country [97] 0 0
Spain
State/province [97] 0 0
San Sebastian,
Country [98] 0 0
Spain
State/province [98] 0 0
Santa Cruz De Tenerife
Country [99] 0 0
Spain
State/province [99] 0 0
Santander
Country [100] 0 0
Spain
State/province [100] 0 0
Sevilla
Country [101] 0 0
Spain
State/province [101] 0 0
Toledo
Country [102] 0 0
Spain
State/province [102] 0 0
Valencia
Country [103] 0 0
Spain
State/province [103] 0 0
Zaragoza
Country [104] 0 0
Switzerland
State/province [104] 0 0
Basel Bs
Country [105] 0 0
Switzerland
State/province [105] 0 0
Basel
Country [106] 0 0
Switzerland
State/province [106] 0 0
Bern
Country [107] 0 0
Switzerland
State/province [107] 0 0
Geneve 14
Country [108] 0 0
Switzerland
State/province [108] 0 0
Lausanne
Country [109] 0 0
Switzerland
State/province [109] 0 0
Lugano
Country [110] 0 0
Switzerland
State/province [110] 0 0
St Gallen
Country [111] 0 0
Switzerland
State/province [111] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen-Cilag International NV
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01508286
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01508286