Status:
COMPLETED
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Open-label pharmacokinetic drug interaction study.
Detailed Description
Multi-center, phase 2, open-label, sequential-cohort, drug interaction study. Cohort 1 subjects (tacrolimus and adefovir dipivoxil) were enrolled first. Based on the findings in Cohort 1, a decision w...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 18-65 years of age
- Greater than or equal to 6 months post-liver transplantation
- Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months.
- Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00644761
Start Date
February 1 2004
End Date
May 1 2005
Last Update
April 10 2008
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
California Pacific Medical Center
San Francisco, California, United States, 94115
4
University of California, San Francisco
San Francisco, California, United States, 94143