Trials / Completed
CompletedNCT00007059
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PROTOCOL OUTLINE: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mycophenolate mofetil |
Timeline
- Start date
- 1998-06-01
- First posted
- 2000-12-07
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00007059. Inclusion in this directory is not an endorsement.