Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-03 @ 11:59 PM
Study NCT ID:
NCT02710604
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2, Multiple Ascending Dose Proof of Concept Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524480', 'term': 'hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients', 'timeFrame': '28 days', 'description': 'Capture adverse events, physical examinations, ECGs and clinical laboratory panels'}, {'measure': 'To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).', 'timeFrame': '28 days', 'description': 'HBV DNA levels'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.', 'timeFrame': '28 days', 'description': 'Measuring Cmax(concentration maximum): the peak plasma concentration.'}, {'measure': 'Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.', 'timeFrame': '28 days', 'description': 'Measuring Tmax(time maximum): the time Cmax was observed.'}, {'measure': 'Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.', 'timeFrame': '28 days', 'description': 'Measuring AUC(area under the curve): area under plasma concentration versus time curve.'}, {'measure': 'Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.', 'timeFrame': '28 days', 'description': 'Measuring Cmin(concentration minimum): minimum observed plasma concentration.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic hepatitis B(CHB)'], 'conditions': ['Infectious Disease']}, 'descriptionModule': {'briefSummary': 'This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.', 'detailedDescription': 'This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of giving written informed consent.\n* Capable of completing study requirements.\n* Chronic hepatitis B positive.\n* HBV treatment naïve.\n\nExclusion Criteria:\n\n* Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).\n* History or medical condition that could impact patient safety.\n* Current or past abuse of alcohol or illicit drugs.\n* Abnormal laboratory value or ECG.\n* Pregnant or breastfeeding.\n* Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.\n* Systemic immunosuppression.\n* Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.'}, 'identificationModule': {'nctId': 'NCT02710604', 'briefTitle': 'Phase 2, Multiple Ascending Dose Proof of Concept Study', 'organization': {'class': 'UNKNOWN', 'fullName': 'ContraVir'}, 'officialTitle': 'A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects', 'orgStudyIdInfo': {'id': 'CTRV-CMX157-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CMX157 5mg versus TDF', 'description': 'CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days', 'interventionNames': ['Drug: CMX157', 'Drug: TDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CMX157 10mg versus TDF', 'description': 'CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days', 'interventionNames': ['Drug: CMX157', 'Drug: TDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CMX157 25mg versus TDF', 'description': 'CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days', 'interventionNames': ['Drug: CMX157', 'Drug: TDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CMX157 50mg versus TDF', 'description': 'CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days', 'interventionNames': ['Drug: CMX157', 'Drug: TDF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CMX157 100mg versus TDF', 'description': 'CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days', 'interventionNames': ['Drug: CMX157', 'Drug: TDF']}], 'interventions': [{'name': 'CMX157', 'type': 'DRUG', 'otherNames': ['lipid conjugate TFV(tenofovir)'], 'description': 'tablet', 'armGroupLabels': ['CMX157 100mg versus TDF', 'CMX157 10mg versus TDF', 'CMX157 25mg versus TDF', 'CMX157 50mg versus TDF', 'CMX157 5mg versus TDF']}, {'name': 'TDF', 'type': 'DRUG', 'otherNames': ['tenofovir disoproxil fumerate'], 'description': '300mg tablet', 'armGroupLabels': ['CMX157 100mg versus TDF', 'CMX157 10mg versus TDF', 'CMX157 25mg versus TDF', 'CMX157 50mg versus TDF', 'CMX157 5mg versus TDF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'John Sullivan-Boylai, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'ContraVir Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ContraVir Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}