Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT04655794
Status:
UNKNOWN
Last Update Posted:
2020-12-07
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)', 'timeFrame': 'Change from Baseline sTREM1 at 2 weeks'}, {'measure': 'sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)', 'timeFrame': 'Change from Baseline sTREM1 at SARs'}, {'measure': 'sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)', 'timeFrame': 'Change from Baseline sTREM1 at 2 weeks'}, {'measure': 'sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)', 'timeFrame': 'Change from Baseline sTREM1 at SARs'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adverse Reaction to Drug', '3HP']}, 'referencesModule': {'references': [{'pmid': '35308376', 'type': 'DERIVED', 'citation': 'Wang TY, Feng JY, Shu CC, Lee SS, Chen CY, Wei YF, Lin CB, Huang WC, Su WJ, Lin SM. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection. Front Microbiol. 2022 Mar 3;13:821066. doi: 10.3389/fmicb.2022.821066. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* close contact with active TB patients\n* patients with autoimmune diseases preceding biological therapy\n* health-care workers\n* other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.\n\nExclusion Criteria:\n\n* age less than 20 years\n* pregnant women\n* active TB or suspected active TB in the clinical evaluation\n* severe liver disease\n* ESRD\n* organ transplantation\n* close contact with a multidrug-resistant TB patient\n* obesity (BMI\\>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.'}, 'identificationModule': {'nctId': 'NCT04655794', 'briefTitle': 'Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment', 'orgStudyIdInfo': {'id': '201800081B0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'had >= grade 2 adverse reactions', 'interventionNames': ['Drug: 3HP']}, {'label': 'had <2 frade 2 adverse reactions', 'interventionNames': ['Drug: 3HP']}], 'interventions': [{'name': '3HP', 'type': 'DRUG', 'description': 'all patients taking 3HP under directly observed preventive therapy (DOPT) program', 'armGroupLabels': ['had <2 frade 2 adverse reactions', 'had >= grade 2 adverse reactions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tsai-Yu Wang, MD', 'role': 'CONTACT', 'email': 'wang5531@gmail.com', 'phone': '886975368076'}], 'facility': 'Institutional Review Board Chang Gung Medical Foundation', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tsai-Yu Wang', 'role': 'CONTACT', 'email': 'wang5531@gmail.com', 'phone': '+886975368076'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}