Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT03900858
Status:
UNKNOWN
Last Update Posted:
2019-04-05
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C018421', 'term': 'rifapentine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 566}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants', 'timeFrame': '3 years', 'description': 'Cumulative rate of culture-confirmed or clinically diagnosed TB disease in participants'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH', 'timeFrame': 'up to 30 days after the last dose of study drug', 'description': 'Percentage of participants with drug discontinuation for any reason and due to adverse drug reactions associated with 1RPT/INH'}, {'measure': 'Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH', 'timeFrame': 'up to 30 days after the last dose of study drug', 'description': 'Percentage of patients with Grade 3 or 4 drug toxicities and deaths associated with 1RPT/INH'}, {'measure': 'Percentage of participants who complete the treatment regimen', 'timeFrame': 'Enrollment up to Month 1 (1RPT/INH)', 'description': 'Percentage of participants who complete the treatment regimen'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rifapentine', 'isoniazid', 'preventive'], 'conditions': ['Silicosis Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '40326358', 'type': 'DERIVED', 'citation': 'Ruan QL, Yang QL, Ma CL, Lin MY, Huang XT, Mao YP, Gao JM, Li JJ, Zhang XN, You ZX, Zheng QQ, Ren YF, Liu XF, Shao LY, Zhang WH. Efficacy and safety of a novel short course rifapentine and isoniazid regimen for the preventive treatment of tuberculosis in Chinese silicosis patients: a pilot study (SCRIPT-TB). Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16.'}]}, 'descriptionModule': {'briefSummary': "Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.\n\nSilicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients.", 'detailedDescription': "Tuberculosis (TB) remains the most important infectious disease in the world. Preventive treatment plays an important role in successful control of TB. For preventive therapy, alternative shortened courses such as 1-month daily rifapentine and isoniazid have been evaluated in HIV-infected individuals for its non-inferiority, safety and convenience compared with traditional monotherapy. And the treatment completion rate is higher. The investigators' previous study showed a 3-month weekly rifapentine and isoniazid regimen had a high protective efficacy but an unsatisfactory completion rate. Therefore, the investigators suppose that a one-month (12-dose) regimen of rifapentine and isoniazid (1RPT/INH) to be equivalent to a 3-month weekly rifapentine and isoniazid regimen with similar efficacy and higher completion rate. Relevant study is lacking in China where the TB burden is high with the incidence rate of 70/100, 000.\n\nSilicosis is a risk factor of Mycobacterium tuberculosis infection. This is an open-label, non-randomized clinical trial to evaluate the efficacy and safety of the 1RPT/INH to prevent tuberculosis (TB) compared with those who do not receive preventive treatment among silicotic patients."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with Silica exposure or diagnosed with silicosis;\n* Age between 18 to 65 years;\n* Willing to provide signed informed consent, or parental consent and participant assent.\n\nExclusion Criteria:\n\n* Clinical or culture confirmed active TB;\n* A history of treatment for \\> 14 consecutive days with a rifamycin or \\> 30 consecutive days with INH during the previous 2 years;\n* A documented history of a completing an adequate course of treatment for active TB or latent TB infection;\n* Allergy to Isoniazid, Rifampin, or Rifapentine;\n* Human immunodeficiency virus (HIV) infection;\n* History of hepatitis B/C infection or liver cirrhosis;\n* Serum Aspartic transaminase (AST) or alanine transaminase (ALT) \\> 2x upper limit of normal or total bilirubin \\>2.5 mg/dL;\n* Receiving immunosuppressants or biological agents;\n* Life expectancy \\<3 years;\n* Mental disorder;\n* Participated in other clinical trials in recent three months;\n* Other conditions that investigates consider not suitable for participate.'}, 'identificationModule': {'nctId': 'NCT03900858', 'acronym': 'TB', 'briefTitle': 'Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Short Course Rifapentine and Isoniazid for the Preventive Treatment of Tuberculosis(SCRIPT-TB)', 'orgStudyIdInfo': {'id': '2017ZX10201302-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isoniazid/ Rifapentine 3 times a week', 'description': 'Intervention：Isoniazid/ Rifapentine 3 times a week given by DOT oral Rifapentine (450mg) plus Isoniazid (400mg) for 12 doses', 'interventionNames': ['Drug: Isoniazid；Rifapentine']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'No preventive treatment Follow up without intervention. Have already done.'}], 'interventions': [{'name': 'Isoniazid；Rifapentine', 'type': 'DRUG', 'otherNames': ['Isoniazid I INH', 'Rifapentine RPT', '1RPT/INH 1HP'], 'description': '1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation', 'armGroupLabels': ['Isoniazid/ Rifapentine 3 times a week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '317500', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Miaoyao Ling, MD', 'role': 'CONTACT', 'email': 'lmy120904@sina.com', 'phone': '+86576-89668099'}, {'name': 'Xitian Huang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Wenling No.1 People's Hospital, Zhejiang", 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}], 'centralContacts': [{'name': 'Qiaoling Ruan, MD', 'role': 'CONTACT', 'email': '10301010198@fudan.edu.cn', 'phone': '(8621)52889999', 'phoneExt': '8123'}, {'name': 'Wenhong Zhang, MD，PhD', 'role': 'CONTACT', 'phone': '(8621)52889999', 'phoneExt': '8123'}], 'overallOfficials': [{'name': 'Wenhong Zhang, MD，PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital of Fudan University，Shanghai，China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Wenling Hospital of Wenzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Division of Infectious Diseases', 'investigatorFullName': 'Wen-hong Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}