Condition: Rifampin-Resistant Pulmonary Tuberculosis · Tuberculosis, Multidrug-Resistant (MDR-TB) · Sponsor: Shanghai Jiatan Pharmatech Co., Ltd
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. Approximately 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. A 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. The study aims to provide robust data to support the use of Sudapyridine as a treatment option for rifampicin-resistant pulmonary tuberculosis.
This description comes directly from the study's public registry record.
Naihui Chu, MD · 010-89509312 · dongchu1994@sina.com
Zhao Jie, Ph.D · 86010-89509157 · jiaojie_zhao@126.com
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| Beijing Chest Hospital affiliated to Capital Medical University | Beijing, Beijing Municipality, China | Enrolling By Invitation |
| Beijing Chest Hospital, Capital Medical University | Beijing, Beijing Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05824871