Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 7:23 PM
Study NCT ID:
NCT00645294
Status:
COMPLETED
Last Update Posted:
2008-03-27
First Post:
2008-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-21', 'studyFirstSubmitDate': '2008-03-21', 'studyFirstSubmitQcDate': '2008-03-21', 'lastUpdatePostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the PK profile of adefovir 0.14 mg/kg and 0.3 mg/kg in children 2-11 years, including dose proportionality of adefovir dipivoxil liquid formulation. To characterize the PK profile of adefovir dipivoxil 10 mg in adoloscents 12-17 years.', 'timeFrame': '8 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'Adefovir dipivoxil', 'Children', 'Adolescents', 'Pharmacokinetics'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'Open-label study of the pharmacokinetics of adefovir dipivoxil in children and adolescents infected with chronic hepatitis B.', 'detailedDescription': 'Children and adolescents with chronic hepatitis B and compensated liver, HBeAg-positive and serum HBV DNA positive (greater than or equal to 1 x 100,000 copies/mL by Roche Amplicor Monitor PCR) received doses of adefovir dipivoxil in a cross-over design. Subjects aged 2-11 received two single doses (0.14 mg/kg and 0.3 mg/kg liquid formulation) and subjects 2-17 received one dose (10 mg liquid formulation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between the ages of 2 and 17 (inclusive) with chronic hepatitis B as evidenced by the following:\n* HBsAg positive for a minimum of 6 months\n* HBeAg positive and HBV DNA greater than or equal to 1 x 100,000 copies/mL at screening\n* Children and adolescents with compensated liver disease\n* ALT levels greater than or equal to 1.2 upper limit of normal (applicable to 7- to 17-year-old children and adolescents only)'}, 'identificationModule': {'nctId': 'NCT00645294', 'briefTitle': 'Open Label Study of Pharmacokinetics and Safety of Dose of Adefovir Dipivoxil in Children and Adolescents With HBV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 1-2 Open-Label Study of the Pharmacokinetics and Safety of a Single Dose of Adefovir Dipivoxil in Children and Adolescents (Aged 2-17) With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'GS-02-517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Group A', 'description': 'ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group', 'interventionNames': ['Drug: Adefovir dipivoxil']}, {'type': 'OTHER', 'label': 'Treatment Group B', 'description': 'ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group', 'interventionNames': ['Drug: Adefovir Dipivoxil']}, {'type': 'OTHER', 'label': 'Treatment Group C', 'description': 'ADV 10 mg single dose on Day 1 in 12-17 year old age group', 'interventionNames': ['Drug: Adefovir Dipivoxil']}], 'interventions': [{'name': 'Adefovir dipivoxil', 'type': 'DRUG', 'description': '0.14 mg/kg on Day 1, followed by 0.3 mg/kg on Day 8', 'armGroupLabels': ['Treatment Group A']}, {'name': 'Adefovir Dipivoxil', 'type': 'DRUG', 'description': '0.3 mg/kg on Day 1, followed by 0.14 mg/kg on Day 8', 'armGroupLabels': ['Treatment Group B']}, {'name': 'Adefovir Dipivoxil', 'type': 'DRUG', 'description': 'ADV 10 mg on Day 1', 'armGroupLabels': ['Treatment Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaries', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'D-60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'J.W. Goethe-Universitat', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': 'D-30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Mid. Hochschule Hannover Kinderklinik', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Kinderklinik der Gutenberg Universitat', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-80337', 'city': 'München', 'country': 'Germany', 'facility': 'Standort Lindwurmstrasse', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'D-42282', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Zentrum fur Kinder und Jugendmedizin der Klinikum', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Oddzial Chorob Infekcyjnych Dzieci', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '04-730', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Gastroenterologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'SE5 9RY', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Elsa Mondou, MD', 'oldOrganization': 'Gilead Sciences'}}}}