Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• patients who received a first liver transplantation,

• presenting with a qualitative or quantitative PCR positive for hepatitis C virus at time of transplantation, whatever the transaminase activity,

• Women of childbearing potential with a negative pregnancy test,

• Male or female patients who agree to use an effective method of contraception,

• patients who signed a written informed consent form to participate in the study,

• patients who are compliant and likely to follow the visits specified by the study protocol

Exclusion Criteria:

• • Preoperative serious renal impairment (serum creatinine levels > 200 µmol/l),

• repeat transplantation,

• multiple organ transplantation,

• transplantation performed with an organ transplant obtained from a living donor or a reduced or shared organ grafts,

• serious concomitant disorder,

• positive serology for HBs antigen or HIV positive at time of enrollment,

• previous history of nonhepatic cancer (except for localized skin cancer),

• presence of a hepatocellular carcinoma, for which the primary lesion exceeds 5 cm or is complicated by portal thrombosis or metastatic disease,

• an investigational product or therapy administered less than one month before entry into the study.