Trial information
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Liver Transplant Patients.
Status: Recruiting
Protocol number: ML21273
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
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. Target sample size is 250.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Liver Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Incidence of biopsy-proven and treated acute rejection Time frame: Up to month 12
Key secondary outcomes: 1. Patient and graft survival; histological evaluation of grafts. Time frame: Month 12
2. Cardiovascular outcomes and renal function Time frame: Month 12
3. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 10/15/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Besancon
- Bordeaux
- Caen
- Clichy
- Creteil
- Grenoble
- Lille
- Lyon
- Marseille
- Montpellier
- Nice
- Paris
- Rennes
- Toulouse
- Villejuif
