Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-05 @ 9:46 AM
Study NCT ID:
NCT00644761
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2008-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106812', 'term': 'adefovir dipivoxil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-07', 'studyFirstSubmitDate': '2008-03-21', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Post-Liver Transplantation', 'Adefovir Dipivoxil', 'Tacrolimus', 'Cyclosporine'], 'conditions': ['Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gileadclinicaltrials.com/pdf/GS-02-531_synopsis.pdf', 'label': 'Study Results'}]}, 'descriptionModule': {'briefSummary': 'Open-label pharmacokinetic drug interaction study.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* Greater than or equal to 6 months post-liver transplantation\n* Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months.\n* Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault method).'}, 'identificationModule': {'nctId': 'NCT00644761', 'briefTitle': 'PK Study of Tacrolimus and Cyclosporine When Co-Administered With Adefovir Dipivoxil in Post-Liver Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GS-02-531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Arm 1', 'description': 'Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days', 'interventionNames': ['Drug: Adefovir Dipivoxil']}], 'interventions': [{'name': 'Adefovir Dipivoxil', 'type': 'DRUG', 'description': 'Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine', 'armGroupLabels': ['Treatment Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Presbyterian Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '55905', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75204', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elsa Mondou, MD', 'oldOrganization': 'Gilead Sciences'}}}}