Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT00007059|
Recruitment Status : Completed
First Posted : December 7, 2000
Last Update Posted : June 24, 2005
OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation.
II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: mycophenolate mofetil||Not Applicable|
Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube bile externalization also have bile collected on postoperative day 7.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Official Title:||Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation|
|Study Start Date :||June 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007059
|United States, North Carolina|
|University of North Carolina School of Medicine|
|Chapel Hill, North Carolina, United States, 27599-7070|
|Study Chair:||Robert E. Dupuis||University of North Carolina|