An efficacy and safety study of Telaprevir in patients with genotype 1 Hepatitis C infection after liver transplantatio

Phase 1

• Conditions: Chronic hepatitis C infection; MedDRA version: 14.0Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004724-35-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-27
• Study Completion: 2014-07-15
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Male or female liver transplant recipient, 18 to 65 years old.
2. First time liver transplant recipient whose primary pre-transplant diagnosis was chronic
hepatitis C and who is genotype 1 HCV RNA infected following transplantation. Genotype 1
must be confirmed during screening.
3. One of the following based on clinical history or by documented HCV RNA and treatment history:
a) Treatment-naïve subject who did not receive any treatment with any approved or
investigational medication or drug regimen for the treatment of HCV prior to liver
transplantation;
OR
b) Treatment-experienced subject who received treatment for HCV prior to liver
transplantation. Where documentation is available, treatment-experienced subjects who were treated with Peg-IFN/RBV and received 80% or more of the intended dose of Peg-IFN/RBV should be categorized based on their response as either:
- Relapser: Subject had an undetectable HCV RNA level at the end of treatment (6 weeks or less after the last dose of medication) but did not achieve SVR;
- Partial responder: Subject had a ? 2 log10 decrease in HCV RNA at approximately Week 12 of previous therapy, but never achieved
undetectable HCV RNA while on treatment;
- Null responder: Subject failed to decrease HCV RNA by ? 2 log10 after approximately 12 weeks of therapy.
4. > 12 months to 10 years post-liver transplant.
5. Subject must be on a stable TAC or CsA containing immunosuppressive regimen defined as no change in immunosuppressive agents and dose for 3 months prior to the screening visit. Low-dose prednisone (average daily dose ? 5 mg) being used as an immunosuppressant is allowed. Subject should not be on dual therapy with TAC and CsA, and combination treatment with mycophenolate mofetil (Cellcept) is not allowed. Subjects may not use any other immunosuppressive agents.
6. Subject must agree to have a liver graft biopsy within the screening period, except:
- A liver graft biopsy does not need to be repeated within the screening period if a liver
graft biopsy was performed within 3 months prior to the screening visit, the biopsy report
is available, and slides can be sent to the study appointed hepatopathologist for
centralized reading.
- A liver graft biopsy does not need to be repeated within the screening period if the subject has had serial (approximately yearly) liver graft biopsies which show a stable stage of hepatic fibrosis over the past 3 years, the last biopsy was performed within 6 months prior to the screening visit, the biopsy report is available, and the slides from this biopsy can be sent to the study appointed hepatopathologist for centralized reading.
7. The last pre-treatment liver graft biopsy report must reveal fibrosis stage (Metavir) F0-F3. Subjects with F0 are only allowed if they also have:
- Necro-inflammation Grade > 2; or
- Alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN).
8. Subject is judged to be in moderately good health (other than HCV infection following liver transplantation) in the opinion of the investigator, on the basis of medical history and physical examination (including vital signs and screening electrocardiogram [ECG]), with any chronic medical conditions being stable.
9. If heterosexually active, a female subject of childbearing potential and a non- vasectomized male subject who has a female partner of childbearing potential must agree to the use of 2 effective methods of contraception from screening onwards until 6 months (female subject)

Exclusion Criteria

Reference is made to section 4.2 Exclusion criteria, pages 43-46 of the Clinical Trial Protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified