Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-27 @ 2:06 PM
Study NCT ID:
NCT00034359
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2002-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'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': 'C099405', 'term': 'dexelvucitabine'}, {'id': 'D019259', 'term': 'Lamivudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2002-04-26', 'studyFirstSubmitQcDate': '2002-04-26', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2002-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['E-antigen Positive', 'Treatment-naive Chronic Hepatitis B', 'Achillion'], 'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.', 'detailedDescription': 'Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.\n* Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.\n* Hepatitis B e-antigen positive.\n* Human immunodeficiency virus negative.\n* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).\n* No need for excluded medications.\n* Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection.\n\nExclusion Criteria:\n\n* Human immunodeficiency virus infection.\n* Hepatitis C co-infection.\n* Concurrent systemic antiviral treatment.\n* Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past.\n* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.\n* Alcohol abuse.\n* Pregnancy or breast-feeding.\n* Inability to tolerate oral medication.\n* Aspartate aminotransferase \\> 7.0 times the upper limit of normal.\n* Alanine aminotransferase \\> 7.0 times the upper limit of normal.\n* Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.\n* Use of any investigational drug.'}, 'identificationModule': {'nctId': 'NCT00034359', 'briefTitle': 'Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults', 'orgStudyIdInfo': {'id': 'ACH443-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ACH-126,443', 'type': 'DRUG', 'otherNames': ['beta-L-Fd4C']}, {'name': 'Lamivudine', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Belgrade', 'country': 'Federal Republic of Yugoslavia', 'facility': 'Clinical Trial Site'}, {'city': 'Novi Sad', 'country': 'Federal Republic of Yugoslavia', 'facility': 'Clinical Trial Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Achillion, a wholly owned subsidiary of Alexion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}