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Open-label pharmacokinetic drug interaction study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Other | Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir Dipivoxil | Drug | Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate pharmacokinetics of tacrolimus or cyclosporine when co-administered with adefovir dipivoxil 10 mg once daily to patients post-liver transplantation | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Cedars Sinai Medical Center |
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| Label | URL |
|---|---|
| Study Results | View source |
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| 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 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C106812 | adefovir dipivoxil |
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