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

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2011

Conditions
Liver Transplantation
Interventions
DRUG

tacrolimus

Tacrolimus started at 0.50 mg/kg b.i.d. starting at D0, by nasogastric tube and then 1 to 2 hours before meals. The dose of tacrolimus will be adjusted as soon as possible to obtain trough concentrations of the product between 10 and 20 µg/L between D0 and 6 months and then between 8 and 15 µg/L after 6 months

DRUG

tacrolimus, ATG

"immunoprophylaxis allowing sparing of steroids in maintenance therapy combining induction therapy with 3 injections of antithymocyte globulins (ATG) (1.5 mg/kg/d at D0, D2 and D4) and tacrolimus at usual dosage.~In this group of patients, the first injection of ATG will be infused over a period of at least 6 hours and will be started as soon as vascular anastomosis has been completed. It will be preceded by an injection of 3 mg/kg/d methylprednisolone. The second injection of ATG at D2, post transplantation will also be infused over 6 hours and will be preceded by an injection of 1 mg/kg methylprednisolone, and then subsequently steroids will be excluded from the treatment. The third and last injection at D4 post transplantation will be administered over a 6-hour period but will not be preceded by steroids.~In this study arm, tacrolimus will be administered as in arm (A)"

DRUG

ATG+mycophénolate mofétil+tacrolimus

"immunoprophylaxis allowing sparing of steroids in maintenance therapy combined with mycophenolate mofetil, at an initial dosage of 2 grams a day, and then adjusted to safety and tolerability in such a way so as to maintain PMN ≥ 750/mm3, and platelet counts ≥ 30000/mm3.~In this study arm, the patients will receive the same doses of ATG and steroids (and according to the same methods) as in arm B. Tacrolimus started at 0.05 mg/kg b.i.d. starting at D0 by nasogastric tube and then 1 to 2 hours before meals. In this study arm, the tacrolimus dose will be reduced: targeted trough concentrations will be between 7 and 12 µg/L between D0 and 6 months and then between 3 et 7 µg/L after 6 months."

Trial Locations (8)

35

Hôpital Pontchaillou, Rennes

13385

La CONCEPTION hospital, Marseille

31500

University Hospital, Toulouse

33076

Hopital Pellegrin Tripode, Bordeaux

34295

Hopital Saint-Eloi, Montpellier

75000

Hôpital Cochin, Paris

94804

Hopital Paul Brousse, Villejuif

06200

Hopital de L'Archet, Nice

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT00538265 - Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation | Biotech Hunter | Biotech Hunter