Oral Sudapyridine for treating rifampicin-resistant pulmonary tuberculosis
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
This study is testing if a new medication called Sudapyridine can help people with rifampicin-resistant pulmonary tuberculosis get better compared to another treatment called bedaquiline.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd Industry-sponsored |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05824871 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical study evaluates the efficacy and safety of Sudapyridine (WX-081) in combination with a background regimen for patients with rifampicin-resistant pulmonary tuberculosis. Approximately 450 participants will be screened and randomized in a 2:1 ratio to receive either Sudapyridine or bedaquiline for 24 weeks, followed by a background regimen period lasting up to 72 weeks. The study employs a randomized, double-blind, active-controlled design to ensure robust data collection on treatment outcomes and safety. A subset of participants will also undergo intensive pharmacokinetic sampling and cardiac safety evaluations.
Who should consider this trial
Good fit: Ideal candidates include adults with a BMI between 15.0 and 28.0 kg/m2, weighing between 40 kg and 90 kg, and diagnosed with rifampicin-resistant pulmonary tuberculosis.
Not a fit: Patients with hematogenous disseminated pulmonary tuberculosis or those allergic to any study drug will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from rifampicin-resistant pulmonary tuberculosis.
How similar studies have performed: Other studies have shown promise in treating multidrug-resistant tuberculosis, but the specific use of Sudapyridine in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg/m2, and 40kg≤ body weight ≤90kg; * 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; * Direct sputum smear positive for acid-fast bacilli (AFB at least 1+); * Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period; * 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. Exclusion Criteria: * • Allergic to any study drug or its ingredients; * A history of alcohol dependence or drug abuse; * With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis; * Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study; * Have taken Bedaquiline before; * HIV-positive patients; * Laboratory obvious abnormalities; * A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia; * Repeated QTcF intervals \> 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment; * Documented cardiovascular diseases; * Peripheral neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress/worsen over the course of the study; optic neuritis; * Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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)
Study contacts
- Principal investigator: Naihui Chu, Ph.D — Beijing Chest Hospital affiliated to Capital Medical University
- Study coordinator: Naihui Chu, MD
- Email: dongchu1994@sina.com
- Phone: 010-89509312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.