Status:
COMPLETED
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients cur...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- single organ recipients of liver allograft;
- CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;
- \>=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);
- negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.
Exclusion
- treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;
- known contraindications to CNI, corticosteroids or CellCept.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00717314
Start Date
May 1 2008
End Date
July 1 2011
Last Update
September 29 2014
Active Locations (11)
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1
Beijing, China, 100039
2
Beijing, China, 100054
3
Changsha, China, 410013
4
Chengdu, China, 610041