Back to resultsPK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adefovir Dipivoxil
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B, Post-Liver Transplantation, Adefovir Dipivoxil, Tacrolimus, Cyclosporine
Eligibility Criteria
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).
Sites / Locations
- University of Alabama at Birmingham
- Cedars Sinai Medical Center
- California Pacific Medical Center
- University of California, San Francisco
- University of Miami
- Beth Israel Deaconess Medical Center
- NYU Medical Center
- Columbia Presbyterian Medical Center
- Mayo Clinic
- University of Pittsburgh
- Baylor Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment Arm 1
Arm Description
Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
Outcomes
Primary Outcome Measures
To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00644761
Brief Title
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 was made on whether to enroll subjects in Cohort 2 (cyclosporine and adefovir dipivoxil)(i.e., if no interaction was observed in Cohort 1, Cohort 2 subjects would not be enrolled). Since no pharmacokinetic interaction was observed in Cohort 1, Cohort 2 was not enrolled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B, Post-Liver Transplantation, Adefovir Dipivoxil, Tacrolimus, Cyclosporine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm 1
Arm Type
Other
Arm Description
Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
Intervention Type
Drug
Intervention Name(s)
Adefovir Dipivoxil
Intervention Description
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
Primary Outcome Measure Information:
Title
To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
Time Frame
21 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.gileadclinicaltrials.com/pdf/GS-02-531_synopsis.pdf
Description
Study Results
Learn more about this trial
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
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