A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
Completed · Not applicable
Conditions studied: Immunosuppression
In brief
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. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.
Key facts
- Study ID
- NCT00336817
- Run by
- University of Pittsburgh
- People needed
- 30
- Starts
- 2006-11-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2017-03-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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