Study to evaluate The Efficacy, Safety And Pharmacokinetics Of Legalon® Sil, Alone Or In Combination With Ribavirin, For The Prevention Of Recurrent Hepatitis C In Liver Transplant Recipients

• Conditions: Recurrent Hepatitis C; MedDRA version: 16.1Level: LLTClassification code 10070678Term: Hepatitis C recurrentSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-000281-38-ES
• Lead Sponsor: Rottapharm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-20
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

1.Signed and dated informed consent before undergoing any trial-related procedures
2.Male or female patient aged between 18 and 70 years inclusive
3.Patient with documented HCV infection
4.Patient with a documented diagnosis of cirrhosis
5.Patient placed on waiting list for liver transplantation
6.Ability to communicate, participate, and comply with the requirements of the entire study [NB: patients that cannot afford the burden of daily visits to the center to receive the daily treatment before LT or patients with baseline characteristics (e.g. rare ABO and Rh blood groups) causing a low chance to receive a compatible graft within 42 days after randomization are eligible for the post-LT treatment only and can be randomized to Treatment Groups D or E].
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1.Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive)
2.Active septic infections at time of screening
3.Previous organ/tissue transplantation other than cornea and hair
4.Patients requiring combined transplantation
5.Use of systemic immunomodulators (including systemic corticosteroids) within 4 weeks of the screening visit or during the screening period
6.Total bilirubin value >10mg/dL [Patients with total bilirubin value >10mg/dL are eligible to receive the post-LT treatment only, and therefore will be randomized to Treatment Groups F or G]
7.Patients not eligible to be treated with ribavirin as per the instructions present in its prescribing information document
8.For females of childbearing potential:
-Pregnancy (i.e. positive pregnancy test at screening) or breast feeding
-Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch).
9.Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom
10.Treatment for HCV with any investigational medication (prior use of silymarin is not exclusionary)
11.Treatment for HCV with any licensed therapies or therapy with any interferon alpha within 30 days of the randomization visit
12.Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study
13.Any known pre-existing medical condition that could interfere with the listing of the patient or with his/her participation in and completion of the study, including but not limited to:
-Chronic pulmonary disease (e.g. clinical chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis)
-Current or history of any clinically significant cardiac abnormalities/dysfunction (e.g. angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension, or history of use of antianginal agents for cardiac conditions
14.Site personnel directly involved in the study or their family members
15.Known hypersensitivity to Legalon® SIL

Study & Design

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