[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Global Alliance for TB Drug Development\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644546","phase-2-sorfequiline-based-regimens-in-adults-with-newly-diagnosed-drug-sensitive-pulmonary-tb-100644546",false,"NCT07672405","Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB","A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis","Inclusion Criteria:\n\n* DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB\n* Of non-childbearing potential OR using effective birth control methods\n* Body weight ≥ 35 k\n\nExclusion Criteria:\n\n* Karnofsky score \\\u003C 60 at screening\n* Any evidence of extrapulmonary TB\n* Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding\n* Laboratory abnormalities as defined in the protocol. • For participants living with HIV only:\n\n  * CD4+ count\\\u003C200 cells\u002FμL.\n  * WHO Clinical Stage 4 HIV disease\n  * Participant does not agree to use DTG\u002FTFV\u002F3TC during study treatment if ARV therapy is indicated\n  * If initiation of ARV therapy is indicated, participants who are known to be intolerant, non-responsive to DTG\u002FTFV\u002F3TC or have DTG\u002FTFV\u002F3TC as a contraindication.","ALL","18 Years","65 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200\u002F100SPaL-4\u002F13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.\n\nParticipants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :\n\n1. a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or\n2. sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.\n\nThe primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure\u002Frelapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.",[27],"Tuberculosis, Pulmonary",[29,30,31,32,33],"tuberculosis","sorfequiline","drug sensitive tuberculosis","pretomanid","linezolid","NOT_YET_RECRUITING","2026-06-26",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2028-06-24",{"name":44,"class":45},"Global Alliance for TB Drug Development","OTHER",11,""]