Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Hepatitis C virus (HCV)-related liver disease is the most common indication for liver transplantation (LT). However, LT does not cure the infection, and therapeutic strategies resulted in very limited efficacy and tolerability in LT recipients. In view of its postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV recurrent patients after liver transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rottapharm
• Collaborator: Azienda Ospedaliera Universitaria Policlinico
• Treatments: Silybin; Silymarin

Criteria

Inclusion Criteria:

• Patients must provide signed and dated informed consent before undergoing any trial related procedure.

• Males or females aged ≥ 18 and ≤ 70.

• Patients with HCV recurrent chronic hepatitis after liver transplantation, not responding to treatment with peginterferon/ribavirin (i.e. the so called standard of care, SOC).

• Stable (≥ 1 year) liver transplanted patients with HCV recurrence (as indicated by positive serum HCV-RNA, increase in transaminases, signs of graft damage according to HCV recurrence and/or presence of liver fibrosis as assessed by Fibroscan).

• Patients without biochemical, clinical and/or histological suspicion of rejection.

• Patients must be able to communicate, participate and comply with the requirements of the entire study.

• Female patients of child-bearing potential must agree on using a contraceptive method (oral contraceptive, intra-uterine device [IUD], transdermal contraceptive patch) and must have a negative pregnancy test at screening.

Exclusion Criteria:

• Patients with active hepatocellular carcinoma or other neoplasia (excluding cutaneous carcinoma in view of the high prevalence in the transplanted population).

• Patients with active biliary tract anomalies.

• Patients with a rejection episode in the 6 months preceding study inclusion.

• Patients on active interferon treatment.

• Female patients who are pregnant or breast-feeding.

• Patients with clinically significant laboratory abnormalities at screening.

• Patients with creatinine clearance < 50 ml.

• Patients with any abnormality on physical examination, vital signs (sitting systolic blood pressure greater than 140 mmHg, sitting diastolic blood pressure greater than 90 mmHg and pulse greater than 80 bpm) and ECG, unless these abnormalities are judged to be not clinically significant by the Investigator (a note about this must be made on the electronic Case Report Form - e-CRF).

• Patients taking any concomitant medication that is not allowed and that cannot be discontinued for the entire study period.

• Patients who are already taking other investigational drugs/treatments or have taken part in a clinical study within the previous 3 months or 5 half lives (whichever is longer).

• Patients with known hypersensitivity to any of the test materials or related compounds.

• Patients with a history of drug, alcohol or other substance abuse or other factors limiting their ability to co-operate during the study.

• Patients not available to attend all the test days and investigations as foreseen by the protocol, or unable to understand the aim, procedure or possible hazards of the study.