Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-04 @ 3:57 PM
Study NCT ID:
NCT00230503
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2005-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C497721', 'term': 'pradefovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2005-09-28', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Safety: Clinical examinations of laboratory tests'}, {'measure': '- Efficacy: Change in viral load over time'}], 'secondaryOutcomes': [{'measure': '- Efficacy: Proportion of patients with undetectable viral load'}]}, 'conditionsModule': {'keywords': ['Hepatitis B, Chronic', 'Hepatitis B Virus', 'Pradefovir Mesylate', 'Adefovir Dipivoxyl'], 'conditions': ['Hepatitis B, Chronic']}, 'referencesModule': {'references': [{'pmid': '34487151', 'type': 'DERIVED', 'citation': 'Gao Y, Kong F, Song X, Shang J, Yao L, Xia J, Peng Y, Liu W, Gong H, Mu M, Cui H, Han T, Chen W, Wu X, Yang Y, Yan X, Jin Z, Wang P, Zhu Q, Chen L, Zhao C, Zhang D, Jin W, Wang D, Wen X, Liu C, Jia J, Mao Q, Ding Y, Jin X, Zhang Z, Mao Q, Li G, Niu J. Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial. Clin Infect Dis. 2022 Jun 10;74(11):1925-1932. doi: 10.1093/cid/ciab763.'}]}, 'descriptionModule': {'briefSummary': '* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment\n* Select the dose of pradefovir for Phase 3 studies', 'detailedDescription': '* Compare the safety of four oral doses of pradefovir after 48 weeks of treatment\n* Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment\n* Select the dose of pradefovir for Phase 3 studies\n* Determine the pharacokinetic profiles of four oral doses of pradefovir'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Compensated chronic HBV Infection\n* No prior treatment with adefovir dipivoxil\n* No interferon or lamivudine treatment for three months prior to enrollment\n* HBeAg positive or negative\n* HBV DNA viral load greater than 500,000 copies per mL\n* ALT between 1.2 and 10 times ULN\n\nExclusion Criteria:\n\n* Positive HIV, HCV, and/or HDV serology\n* History of renal tubular necrosis\n* Serum creatinine greater than 2.0 mg/dl\n* History of organ transplant or use of immunosuppresive drugs\n* Pregnant or breast-feeding females'}, 'identificationModule': {'nctId': 'NCT00230503', 'briefTitle': 'Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B', 'orgStudyIdInfo': {'id': 'RNA200103-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pradefovir mesylate', 'type': 'DRUG'}, {'name': 'adefovir dipivoxyl', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ralph T. Doyle', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health Americas, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}