Status:
COMPLETED
Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Immunosuppression
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued a...
Detailed Description
This is a prospective, single center, open-label, safety and tolerability study on the use of Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI symptoms (na...
Eligibility Criteria
Inclusion
- ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age
- Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen
- Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
- Patients must be more than 30 days post-transplant to be eligible
- Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period
Exclusion
- Multi-organ transplant patients
- HIV positive patients.
- Living-related liver transplant recipients
- Pregnant patients
- Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
- Patients with thrombocytopenia (\<50,000/mm3), with an absolute neutrophil count of \<1,000/mm3 and/or leukocytopenia (\<2,000/mm3), and/or hemoglobin \<7.0 g/dL prior to enrollment
- Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease)
- Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus
- Evidence of drug and/or alcohol abuse
- Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00336895
Start Date
November 1 2006
End Date
November 1 2008
Last Update
November 7 2016
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213