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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• patients receiving their first heart transplant (single organ transplant).

Exclusion Criteria:

• patients with a positive donor-specific cross-match at the time of transplantation;

• patients with any antibody-treated acute rejection;

• known contraindications to treatment with sirolimus;

• history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.