Status:
RECRUITING
A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
Lead Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Conditions:
Rifampin-Resistant Pulmonary Tuberculosis
Tuberculosis, Multidrug-Resistant (MDR-TB)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
This Phase III clinical study is designed to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with a background regimen (BR) for the treatment of rifampicin-resistant pulmonary...
Eligibility 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.
Key Trial Info
Start Date :
September 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 22 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05824871
Start Date
September 2 2022
End Date
October 22 2026
Last Update
June 29 2025
Active Locations (2)
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1
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101149
2
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101149