PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-05-31

Brief Summary

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Open-label pharmacokinetic drug interaction study.

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Detailed Description

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm 1

Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days

Group Type OTHER

Adefovir Dipivoxil

Intervention Type DRUG

Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine

Interventions

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Adefovir Dipivoxil

Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No