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

Toulouse University Hospital

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: ATG+mycophénolate mofétil+tacrolimus; Drug: tacrolimus; Drug: tacrolimus, ATG

Study type: Interventional

Funder types: Other

Identifiers

NCT00538265

0404003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

A

Active Comparator group

Description:

tacrolimus + steroids

Treatment:

Drug: tacrolimus

B

Experimental group

Description:

ATG+ tacrolimus without steroids in maintenance therapy

Treatment:

Drug: tacrolimus, ATG

C

Experimental group

Description:

ATG+ Mycophenolate Mofetil + tacrolimus a reduced dosage without steroids in maintenance therapy

Treatment:

Drug: ATG+mycophénolate mofétil+tacrolimus