Status:
COMPLETED
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic 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 compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellC...
Detailed Description
This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellula...
Eligibility Criteria
Inclusion
- ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age.
- Patients must be 30 to 180 days (1 to 6 months) post-transplant to be eligible.
- Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen.
- Patients with renal insufficiency (history of renal insufficiency or renal failure in the past, patients on hemodialysis, patients with a rising creatinine post-transplant).
- Patients with biopsy-proven acute cellular rejection (mild, moderate, or severe based on Rejection Activity Index (RAI) as graded by pathologists at UPMC) or repeated bouts of rejection (greater than 2 episodes within a 30 day period).
- Patients with tacrolimus- or cyclosporine-induced neurotoxicity.
- 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 and nursing mothers.
- 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.
- Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, 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 :
30 Patients enrolled
Trial Details
Trial ID
NCT00336817
Start Date
November 1 2006
End Date
November 1 2008
Last Update
March 9 2017
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213