Clinical trial NCT00538265: Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation
Official title: Evaluation of the Benefit of Antithymocyte Induction Therapy on Hepatic Fibrosis in de Novo Hepatitis C Virus Liver Transplant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: liver transplantation, hepatitis C virus, immunoprophylaxis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary endpoint will be degree of fibrosis = Ishak's histological score of hepatic biopsy at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: • Ishak's degree of activity
timeFrame: 1 year
measure: Ishak's degree of fibrosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin Tripode
city: Marseille
country: France
facility: La CONCEPTION hospital
city: Montpellier
country: France
facility: Hopital Saint-Eloi
city: Nice
country: France
facility: Hopital de L'Archet
city: Paris
country: France
facility: Hôpital Cochin
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Toulouse
country: France
facility: University Hospital
city: Villejuif
country: France
facility: Hopital Paul Brousse
Study officials:
affiliation: University Hospital, Toulouse
name: Rostaing Lionel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UHCochin, Paris
name: Calmus Yvon, PhD
role: PRINCIPAL_INVESTIGATOR
References: