[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502639":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":73,"collaborators":32,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":32,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":64,"whyStopped":32,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Shanghai Jiatan Pharmatech Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sudapyridine (WX-081) Group","EXPERIMENTAL","Participants in this group will receive Sudapyridine (WX-081) combined with background regimen (BR). Treatment starts with a loading dose of Sudapyridine for 2 weeks (450 mg once daily for 7 days, followed by 300 mg once daily for 7 days). This is followed by a maintenance dose of 150 mg once daily from Week 3 to Week 24. During the 24-week treatment period, participants will also receive a placebo for bedaquiline and continue their background regimen (BR). After the 24-week treatment period, participants will enter the background regimen phase and continue BR until Week 72.",[13],"Drug: Sudapyridine",{"label":15,"type":16,"description":17,"interventionNames":18},"Bedaquiline Group","ACTIVE_COMPARATOR","Participants in this group will receive Bedaquiline combined with background regimen (BR). Treatment starts with a loading dose of Bedaquiline for 2 weeks (400 mg once daily), followed by a maintenance dose of 200 mg three times per week (with at least 48 hours between doses) from Week 3 to Week 24. During the 24-week treatment period, participants will also receive a placebo for Sudapyridine and continue their background regimen (BR). After the 24-week treatment period, participants will enter the background regimen phase and continue BR until Week 72.",[19],"Drug: Bedaquiline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sudapyridine","Sudapyridine (WX-081) will be administered as a loading dose for 2 weeks (450 mg once daily for 7 days, followed by 300 mg once daily for 7 days) and a maintenance dose (150 mg once daily) from Week 3 to Week 24. The intervention is combined with background regimen (BR) and placebo for bedaquiline.",[9],[27],"WX-081",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Bedaquiline","Bedaquiline will be administered as a loading dose for 2 weeks (400 mg once daily) and a maintenance dose (200 mg three times per week, with at least 48 hours between doses) from Week 3 to Week 24. The intervention is combined with background regimen (BR) and placebo for Sudapyridine.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Naihui Chu, Ph.D","Beijing Chest Hospital affiliated to Capital Medical University","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Naihui Chu, MD","CONTACT","010-89509312","dongchu1994@sina.com",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Zhao Jie, Ph.D","86010-89509157","jiaojie_zhao@126.com",[49,62],{"facility":36,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":32},"ENROLLING_BY_INVITATION","Beijing","Beijing Municipality","101149","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},{"facility":63,"status":64,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Beijing Chest Hospital, Capital Medical University","RECRUITING",{"type":57,"coordinates":66},[59,60],{"lat":60,"lon":59},[69],{"name":70,"role":41,"phone":71,"phoneExt":32,"email":72},"Chu Nai Hui, M.D","+86-010-89509312","dongchu@sina.com",{"type":74,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":87,"type":88},450,"ESTIMATED","INTERVENTIONAL",[91],"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.",[94,95],"Rifampin-Resistant Pulmonary Tuberculosis","Tuberculosis, Multidrug-Resistant (MDR-TB)",[97,98,99,100,29,101,102,103],"Rifampin-Resistant Tuberculosis","Multidrug-Resistant Tuberculosis (MDR-TB)","Pulmonary Tuberculosis","Sudapyridine (WX-081)","Antitubercular Agents","Randomized Controlled Trial","Background Regimen Therapy","2025-06-25",{"date":106,"type":107},"2025-06-29","ACTUAL",{"date":109,"type":107},"2022-09-02",{"date":111,"type":88},"2026-10-22",{"name":5,"class":6},2]