Clinical trial NCT01571583: An Efficacy and Safety Study of Telaprevir in Patients With Genotype 1 Hepatitis C Infection After Liver Transplantation
Official title: Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus (HCV) Infection
Keywords: Chronic HCV infection
Genotype 1 chronic HCV
Liver transplantation
Hepatitis C
Hep C
HCV
Telaprevir
Pegylated-Interferon-alfa-2a
Ribavirin
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.

Detailed description: This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Eligibility criteria: Inclusion Criteria:

* First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
* More than 6 months to 10 years post-liver transplant
* Patient did or did not receive treatment for HCV prior to liver transplantation
* Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin

Exclusion Criteria:

* Patient is currently infected or co-infected with HCV of another genotype than genotype 1
* Patient received treatment for hepatitis C following liver transplantation
* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Patient with human immunodeficiency virus or hepatitis B virus co-infection
* Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)

Primary outcomes:
measure: Number of patients achieving sustained virologic response (SVR) 12 planned
timeFrame: Week 60
Secondary outcomes:
measure: Number of patients achieving SVR12 planned(c)
timeFrame: Week 60
measure: Number of patients achieving SVR24 planned
timeFrame: Week 72
measure: Number of patients achieving SVR24 planned(c)
timeFrame: Week 72
measure: Number of patients having an undetectable HCV RNA level at Week 4 of treatment
timeFrame: Week 4
measure: Number of patients having an undetectable HCV RNA level at Week 12 of treatment
timeFrame: Week 12
measure: Number of patients having undetectable HCV RNA levels at Week 4 and Week 12 of treatment
timeFrame: Week 4 and Week 12
measure: Number of patients having an undetectable HCV RNA level at the actual end of treatment
timeFrame: Week 48
measure: Number of patients having an undetectable HCV RNA level at the planned end of treatment
timeFrame: Week 48
measure: Number of patients having less than 25 IU/mL at the planned end of treatment
timeFrame: Week 48
measure: Number of patients with on-treatment virologic failure
timeFrame: Week 48
measure: Number of patients with relapse after undetectable HCV RNA at actual end of treatment
timeFrame: Week 48
measure: Number of patients with relapse after undetectable HCV RNA at planned end of treatment
timeFrame: Week 48
measure: Number of patients with relapse after previous HCV RNA less than 25 IU/mL at planned end of treatment
timeFrame: Week 48
measure: Number of patients with viral breakthrough
timeFrame: Week 48
measure: Change from baseline in log HCV RNA values
timeFrame: Up to Week 52
measure: Number of patients who have changes in liver graft biopsy histology
timeFrame: Up to Week 72
measure: Number of patients with adverse events
timeFrame: Up to Week 72
Other outcomes:
Locations:
city: Linz
country: Austria
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Clichy
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Rennes Cedex N/A
country: France
city: Villejuif Cedex
country: France
city: Essen
country: Germany
city: Frankfurt A. M.
country: Germany
city: Hannover
country: Germany
city: Leipzig
country: Germany
city: Münster
country: Germany
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV, Belgium Clinical Trial
role: STUDY_DIRECTOR
References: