A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.

PHASE4CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Liver Transplantation
Interventions
DRUG

Mycophenolate mofetil, adjusted dose

3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.

DRUG

Tacrolimus

Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12

DRUG

Corticosteroids, IV

10-15 mg/kg IV pre-operation on Day 0

DRUG

Mycophenolate mofetil, Standard dose

2 g/d PO BID during meals from Day 0 to Month 12

DRUG

Corticosteroids, PO

20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.

Trial Locations (16)

13385

Marseille

14033

Caen

25030

Besançon

31059

Toulouse

33076

Bordeaux

34295

Montpellier

35033

Rennes

38043

Grenoble

59037

Lille

69317

Lyon

69437

Lyon

75679

Paris

92118

Clichy

94010

Créteil

94804

Villejuif

06202

Nice

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00545402 - A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients. | Biotech Hunter | Biotech Hunter