PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
A Multi-Center Phase 2, Open-Label Study to Evaluate the Pharmacokinetics of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil 10 mg to Patients Post-Liver Transplantation
1 other identifier
interventional
16
1 country
11
Brief Summary
Open-label pharmacokinetic drug interaction study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2004
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedApril 10, 2008
April 1, 2008
1.2 years
March 21, 2008
April 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
21 days
Secondary Outcomes (1)
To evaluate PK of ADV 10 mg once daily when co-administered with tacrolimus or cyclosporine in patients post-liver transplantation. To evaluate the safety of ADV 10 mg once daily, when co-administered with tacrolimus or cyclosporine for 14 days.
21 days
Study Arms (1)
Treatment Arm 1
OTHERAdefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
Interventions
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (11)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Miami
Miami, Florida, 33136, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
NYU Medical Center
New York, New York, 10016, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Mayo Clinic
Rochester, New York, 55905, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Baylor Research Institute
Dallas, Texas, 75204, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 27, 2008
Study Start
February 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
April 10, 2008
Record last verified: 2008-04