Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-03-05 @ 5:41 AM
Study NCT ID:
NCT03597633
Status:
UNKNOWN
Last Update Posted:
2018-07-24
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenofovir Combination or Mono-therapy for MDR CHB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse event', 'timeFrame': '36 months, 60 months', 'description': 'Any untoward event related or not related to the study medication'}], 'primaryOutcomes': [{'measure': 'Virologic Response', 'timeFrame': '36 months', 'description': 'undetectable HBV DNA (\\<20 IU/mL)'}], 'secondaryOutcomes': [{'measure': 'Virologic Response', 'timeFrame': '60 months', 'description': 'undetectable HBV DNA (\\<20 IU/mL)'}, {'measure': 'mean HBV DNA', 'timeFrame': '36 months, 60 months', 'description': 'mean HBV DNA levels'}, {'measure': 'ALT normalization', 'timeFrame': '36 months, 60 months', 'description': 'rates of ALT normalization'}, {'measure': 'Hepatitis B e antigen (HBeAg) seroconversion', 'timeFrame': '36 months, 60 months', 'description': 'rates of Hepatitis B e antigen (HBeAg) seroconversion'}, {'measure': 'virologic breakthrough', 'timeFrame': '36 months, 60 months', 'description': 'Incidence of virologic breakthrough defined by increase of HBV DNA more than 1 log IU/mL from nar dir.'}, {'measure': 'Genotypic resistance', 'timeFrame': '36 months, 60 months', 'description': 'Detection of previously known mutations to be resistant to the drugs being administered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis b With Multidrug Resistance']}, 'descriptionModule': {'briefSummary': 'Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.', 'detailedDescription': 'Inclusion criteria were CHB patients with resistance to more than two classes of nucleos(t)ide analogues (NA) and hepatitis B virus (HBV) DNA level ≥200 IU/mL.\n\nPatients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (\\<20 IU/mL) at month 36.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic hepatitis B patients with multiple drug resistance.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CHB patients with:\n\n 1. documented HBsAg positivity at least 6 months before enrollment\n 2. age \\>18 years old,\n 3. confirmed genotypic resistance to more than two classes of NAs\n 4. HBV DNA level ≥ 200 IU/mL\n 5. compensated liver diseases (defined by Child-Pugh-Turcotte score \\<7; prothrombin time \\<3 seconds above upper limit of normal or international normalized ratio \\<1.5; serum albumin \\>3 g/dL; total bilirubin \\<2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy)\n 6. willingness to give an informed consent.\n\nExclusion Criteria:\n\n1. laboratory abnormalities of low serum phosphorous level \\<2.0 mEq/dL, elevated serum creatinine \\>1.5 mg/dL, decreased creatinine clearance rate \\<50 mL/min, absolute neutrophil count \\<1000 cell/mL, or low hemoglobin level \\<10 g/dL (if female, \\<9 g/dL)\n2. no definite evidence of genotypic resistance\n3. positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus\n4. HCC\n5. a proof of pregnant or lactating women\n6. evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)\n7. any untreated malignancy.'}, 'identificationModule': {'nctId': 'NCT03597633', 'briefTitle': 'Tenofovir Combination or Mono-therapy for MDR CHB', 'organization': {'class': 'OTHER', 'fullName': 'Korea University'}, 'officialTitle': 'Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'MDRCHB'}}, 'contactsLocationsModule': {'locations': [{'zip': '15355', 'city': 'Ansan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.21795, 'lon': 127.55845}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yonsei University', 'class': 'OTHER'}, {'name': 'CHA University', 'class': 'OTHER'}, {'name': 'Soon Chun Hyang University', 'class': 'OTHER'}, {'name': 'Chonbuk National University', 'class': 'OTHER'}, {'name': 'Hallym University', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyung Joon Yim', 'investigatorAffiliation': 'Korea University'}}}}