Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-22 @ 2:46 PM
Study NCT ID:
NCT04069858
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'CHB patients receiving treatment with Baraclude® 1 mg alone or in combination with other nucleos(t)ide analogues for 12 months or longer after the development of antiviral resistance.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-24', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-detection rate of hepatitis B virus DNA', 'timeFrame': '12 months', 'description': 'undetectable HBV DNA (\\<20 IU/mL) at 12 months after switching treatment.'}], 'secondaryOutcomes': [{'measure': 'Normalization of liver enzyme', 'timeFrame': '12 months', 'description': 'ALT \\< 40 IU/L'}, {'measure': 'Loss of serological markers of hepatitis B e antigen', 'timeFrame': '12 months', 'description': 'Loss of HBeAg'}, {'measure': 'Signs of newly developing antiviral resistance', 'timeFrame': '12 months', 'description': 'Elevation of hepatitis B virus DNA by 10 fold assessed by real time PCR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '28427875', 'type': 'BACKGROUND', 'citation': 'European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017 Aug;67(2):370-398. doi: 10.1016/j.jhep.2017.03.021. Epub 2017 Apr 18.'}, {'pmid': '29405329', 'type': 'BACKGROUND', 'citation': 'Terrault NA, Lok ASF, McMahon BJ, Chang KM, Hwang JP, Jonas MM, Brown RS Jr, Bzowej NH, Wong JB. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-1599. doi: 10.1002/hep.29800. No abstract available.'}, {'pmid': '31185710', 'type': 'BACKGROUND', 'citation': 'Korean Association for the Study of the Liver (KASL). KASL clinical practice guidelines for management of chronic hepatitis B. Clin Mol Hepatol. 2019 Jun;25(2):93-159. doi: 10.3350/cmh.2019.1002. Epub 2019 Jun 12. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance.\n\nThe primary aim is virological response (\\<20 IU/mL) at 12 months', 'detailedDescription': 'This study is a prospective single-arm open-label trial. The primary endpoint is virological response (\\<20 IU/mL) at 12 months after switching treatment.\n\nPatients who satisfy the inclusion and exclusion criteria will switch from Baraclude® 1 mg to Baracle®. Assessment of treatment response at 12 months is performed by comparing undetectable HBV DNA rates between baseline and 12 months after switching therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>19 years old CHB patients\n* Confirmed antiviral resistance\n* Taking brand entecavir 1 mg for more than 1 year\n* HBV DNA \\< 20 IU/mL\n* Compensated liver cirrhosis\n* Willing to participate\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria\n* Cr\\>1.5 mg/dL\n* Postive HCV Ab\n* Decompensated cirrhosis\n* Pregnant women\n* HCC\n* Alcoholics'}, 'identificationModule': {'nctId': 'NCT04069858', 'briefTitle': 'Maintaining Antiviral Efficacy After Switching to Generic Entecavir 1 mg for Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Korea University'}, 'officialTitle': 'Maintaining Antiviral Efficacy After Switching to Generic Entecavir, Baracle® in Patients Taking Baraclude® 1 mg for Antiviral Resistant Chronic Hepatitis B; A Noninferiority Study Assessing Non-detection Rate of Hepatitis B Virus DNA', 'orgStudyIdInfo': {'id': '2106AS0033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baracle', 'description': 'Chronic hepatitis B patients who swiched to Baracle® 1 mg from Baraclude® 1 mg treatment as mono- or combination therapy after the development of antiviral resistance to nucleos(t)ide analogues', 'interventionNames': ['Drug: Switching to Generic Entecavir (Baracle®)']}], 'interventions': [{'name': 'Switching to Generic Entecavir (Baracle®)', 'type': 'DRUG', 'otherNames': ['Antiviral therapy'], 'description': 'switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)', 'armGroupLabels': ['Baracle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15355', 'city': 'Ansan', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.21795, 'lon': 127.55845}}], 'overallOfficials': [{'name': 'Hyung Joon Yim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyung Joon Yim', 'investigatorAffiliation': 'Korea University'}}}}