Clinical trial NCT00644761: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B
Post-Liver Transplantation
Adefovir Dipivoxil
Tacrolimus
Cyclosporine
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation
timeFrame: 21 days
Secondary outcomes:
measure: 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.
timeFrame: 21 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Rochester
country: United States
facility: Mayo Clinic
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
References: