Clinical trial NCT00545402: A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
Official title: A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 180
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: This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* recipient of a first orthotopic liver transplant.

Exclusion Criteria:

* history of organ transplants;
* patient receiving a multi-organ transplant;
* calculated creatinine clearance \<=30mL/min before transplant;
* leukocyte count \< 2000/mm3 at randomization;
* history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
* pregnant or breast-feeding females, or females of childbearing age not using effective contraception.

Primary outcomes:
measure: Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant
timeFrame: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment
Secondary outcomes:
measure: Percentage of Participants With Graft Loss
timeFrame: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
measure: Graft Survival
timeFrame: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.
measure: Overall Survival (OS) at Month 12 - Percentage of Participants With an Event
timeFrame: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
measure: Overall Survival at Month 12
timeFrame: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
measure: Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review
timeFrame: Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12
Other outcomes:
Locations:
city: Besancon
country: France
city: Bordeaux
country: France
city: Caen
country: France
city: Clichy
country: France
city: Creteil
country: France
city: Grenoble
country: France
city: Lille
country: France
city: Lyon cedex 3
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Rennes
country: France
city: Toulouse
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: