[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rifampin-resistant-pulmonary-tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rifampin-resistant-pulmonary-tuberculosis":28},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100502639","phase-3-a-phase-iii-study-of-oral-sudapyridine-wx-081-tablets-in-rifampicin-resistant-pulmonary-tuberculosis-patients-100502639",false,"NCT05824871","A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients","A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Oral Sudapyridine (WX-081) Tablets in Patients With Rifampicin-Resistant Pulmonary Tuberculosis","WISH","Inclusion Criteria:\n\n* • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg\u002Fm2, and 40kg≤ body weight ≤90kg;\n\n  * For clinically diagnosed patients with tuberculosis whose drug sensitivity test has proved to be at least resistant to rifampicin, phenotypic or molecular drug sensitivity test results within 3 months before the subject signs informed consent can be accepted;\n  * Direct sputum smear positive for acid-fast bacilli (AFB at least 1+);\n  * Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period;\n  * Non-lactating and pregnant women who agree to use contraception throughout the treatment; Or the male patient's spouse agrees to use contraception throughout the treatment.\n\nExclusion Criteria:\n\n* • Allergic to any study drug or its ingredients;\n\n  * A history of alcohol dependence or drug abuse;\n  * With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis;\n  * Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study;\n  * Have taken Bedaquiline before;\n  * HIV-positive patients;\n  * Laboratory obvious abnormalities;\n  * A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia;\n  * Repeated QTcF intervals \\> 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment;\n  * Documented cardiovascular diseases;\n  * Peripheral neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress\u002Fworsen over the course of the study; optic neuritis;\n  * Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.","ALL","18 Years","65 Years",{"count":21,"type":22},450,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a multicenter, randomized, double-blind, active-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) combined with a background regimen (BR) in patients with rifampicin-resistant pulmonary tuberculosis.\n\nApproximately 450 participants will be screened over a period of up to 2 weeks and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline, in combination with placebo tablets and BR, for 24 weeks. After the treatment period, participants will enter a background regimen period up to Week 72, during which they will continue to receive BR.\n\nA subset of participants will be included in the C-QT sub-study to assess intensive PK sampling and 12-lead ECG evaluations on Day 1 pre-dose, Day 14, and Week 24.\n\nThe study aims to provide robust data to support the use of Sudapyridine as a treatment option for rifampicin-resistant pulmonary tuberculosis.",[28,29],"Rifampin-Resistant Pulmonary Tuberculosis","Tuberculosis, Multidrug-Resistant (MDR-TB)",[31,32,33,34,35,36,37,38],"Rifampin-Resistant Tuberculosis","Multidrug-Resistant Tuberculosis (MDR-TB)","Pulmonary Tuberculosis","Sudapyridine (WX-081)","Bedaquiline","Antitubercular Agents","Randomized Controlled Trial","Background Regimen Therapy","RECRUITING","2025-06-25",{"date":42,"type":43},"2025-06-29","ACTUAL",{"date":45,"type":43},"2022-09-02",{"date":47,"type":22},"2026-10-22",{"name":49,"class":50},"Shanghai Jiatan Pharmatech Co., Ltd","INDUSTRY",2]