[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Barwon Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100553059","phase-2-telacebec-t-treatment-in-adults-with-buruli-ulcer-bu-treat-bu-100553059",false,"NCT06481163","Telacebec (T) Treatment in Adults With Buruli Ulcer (BU). (TREAT BU)","A Phase 2 Multicentre, Open-label Study to Evaluate the Efficacy, Safety and Tolerability, and Pharmacokinetics of 14 -28 Days Telacebec Treatment in Adult Participants With Buruli Ulcer.","Major Inclusion Criteria:\n\n* Clinical diagnosis of BU WHO categories, single or multiples:\n\nCategory I- a single lesion \\\u003C 5 cm Category II - a single lesion with cross-sectional diameter ≤ 10 cm Category III - where multiple and all lesions are ≤ 10 cm cross-sectional diameter\n\n* Positive PCR or culture for confirmation of presence of mycobacterium ulcerans (MU).\n* Aged 18 years and older, except for those included in exclusion below.\n\nMajor Exclusion Criteria:\n\n* Participants with the following known or suspected medical conditions\u002Fcriteria:\n\n  1. Any non BU related condition where participation in the study, as judged by the Investigator, could compromise the well-being of the participant or prevent, limit or confound protocol specified treatment and assessments.\n  2. History or current ascites, jaundice, myasthenia gravis, clinically significant renal dysfunction \\[estimated glomerular filtration rate (eGFR) \\\u003C 30 mls\u002Fmin\\],\n  3. Compromised immune status (e.g. uncontrolled HIV-infection)\n  4. History of previous BU in the previous 12 months (except current infection)\n  5. Participants who fulfill both of the following criteria:\n\n     * Aged ≥ 60 years\n     * Weight ≥ 85 kg\n* Planned\u002Fexpected to require curative intent excision surgery, defined as excision of lesion which may include surrounding macroscopically healthy tissue with the aim of helping to sterilize the wound rather than improve wound healing alone, for their BU during the entire study period. Simple removal of necrotic slough and skin grafting is considered normal wound care and allowed.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this interventional clinical trial is to demonstrate the complete BU lesion healing rate by 52 weeks after treatment initiation, without relapse and\u002For curative intent excision surgery, after 10-28 days of telacebec (T) treatment. Males and females age 18 and older will be included.\n\n• Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.",[26],"Buruli Ulcer",[28,29,26,30,31],"lesion","ulcer","telacebec","Q203","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2024-07-09",{"date":40,"type":20},"2028-01",{"name":42,"class":43},"Barwon Health","OTHER_GOV",2,""]