PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00644761
First received: March 21, 2008
Last updated: April 7, 2008
Last verified: April 2008
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Purpose
Open-label pharmacokinetic drug interaction study.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: Adefovir Dipivoxil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
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 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
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. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | February 2004 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment Arm 1
Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days
|
Drug: Adefovir Dipivoxil
Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644761
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| NYU Medical Center | |
| New York, New York, United States, 10016 | |
| Mayo Clinic | |
| Rochester, New York, United States, 55905 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Baylor Research Institute | |
| Dallas, Texas, United States, 75204 | |
Sponsors and Collaborators
Gilead Sciences
More Information
Additional Information:
No publications provided
| Responsible Party: | Elsa Mondou, MD, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT00644761 History of Changes |
| Other Study ID Numbers: | GS-02-531 |
| Study First Received: | March 21, 2008 |
| Last Updated: | April 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
Hepatitis B Post-Liver Transplantation Adefovir Dipivoxil Tacrolimus Cyclosporine |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Cyclosporins Cyclosporine Adefovir |
Adefovir dipivoxil Tacrolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antiviral Agents Reverse Transcriptase Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013