Trial information
A Study of CellCept (Mycophenolate Mofetil) in Heart Transplant Patients.
Status: Completed
Protocol number: M55021
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to evaluate pharmacokinetic variability of CellCept in association with cyclosporine and corticosteroids in primary orthotopic heart transplant patients
Brief summary: This study will evaluate the pharmacokinetic variability (in terms of AUC) of CellCept in association with cyclosporine and corticosteroids, in primary orthotopic heart transplant patients. Within 72 hours of transplantation, patients will be randomized to one of 2 groups; one group will remain on a fixed dose of CellCept for 3 months, and the other will have their dose adjusted in order to maintain an AUC of mycophenolate mofetil within a target range. CellCept treatment (plus cyclosporine and corticosteroids) will continue for a further 9 months. The anticipated time on study treatment is 3-12 months, and the target sample size is < 100 individuals. Target sample size is 50.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Parallel; Pharmacokinetics study
Condition: Heart Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Pharmacokinetics:AUC 0-12 of mycophenolic acid. Efficacy: Acute rejection rate; allograft artery disease incidence; overall survival.
Key secondary outcomes: 1. Safety: AEs; opportunistic infection; malignancy.
Inclusion criteria:
- adult patients, 18-65 years of age;
- undergoing primary orthotopic heart transplantation.
Exclusion criteria:
- recipients of previous or multiple organ transplant;
- patients who have previously received CellCept;
- patients with malignancies or history of malignancy, except successfully treated basal or squamous cell cancer of the skin.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Milano
- Napoli
- Pavia
- Udine
