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

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: tacrolimus, ATG; Drug: ATG+mycophénolate mofétil+tacrolimus; Drug: tacrolimus

• Registration Number: NCT00538265
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Primary Completion: 2010-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-02
• Last Update Posted: 2011-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	tacrolimus, ATG	ATG+ tacrolimus without steroids in maintenance therapy
C	ATG+mycophénolate mofétil+tacrolimus	ATG+ Mycophenolate Mofetil + tacrolimus a reduced dosage without steroids in maintenance therapy
A	tacrolimus	tacrolimus + steroids

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year	1 year

Secondary Outcome Measures

Name	Time	Method
• Ishak's degree of activity	1 year
Ishak's degree of fibrosis	2 years

Trial Locations

Locations (8)

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital Cochin; 🇫🇷 Paris, France

Hopital Paul Brousse; 🇫🇷 Villejuif, France

University Hospital; 🇫🇷 Toulouse, France

Hopital Pellegrin Tripode; 🇫🇷 Bordeaux, France

La CONCEPTION hospital; 🇫🇷 Marseille, France

Hopital Saint-Eloi; 🇫🇷 Montpellier, France

Hopital de L'Archet; 🇫🇷 Nice, France