NCT02091414

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

An Open Label Study to Evaluate the Effect of CellCept in Combination With Cyclosporine A and Steroids on Renal Function and the Prevention of Acute Rejection in Heart Transplant Patients.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DRUG	mycophenolate mofetil (MMF)	1.0 g PO BID
DRUG	cyclosporine A (CsA)	Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL
DRUG	corticosteroids	As per the practice of each participating center

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2014-03-19
• Last updated: 2014-10-29
• Results posted: 2014-10-29

Locations

3 sites across 1 country: China