Clinical trial
A Multicenter, Randomized, Double-blind, Positive Control Study to Evaluate the Efficacy and Safety of Sudapyridine (WX-081) Tables in Patients With Rifampicin-resistant Pulmonary Tuberculosis
Name
JYP0081M301
Description
The objective of this study is to demonstrate that the antibacterial activity of Sudapyridine (WX-081) is not inferior to Bedaquiline when added to a Background Regimen (BR) for treatment of rifampicin- resistant TB. Also, safety and clinical outcome will be evaluated.
Trial arms
Trial start
2022-09-02
Estimated PCD
2025-01-22
Trial end
2025-03-22
Phase
Early phase I
Treatment
Sudapyridine
Two weeks of loading dose followed by twenty-two weeks of maintenance dose Drug: Background regimen (BR) for RR-TB Background regimen (BR) for RR-TB selected according to WHO and local guidelines for up to 72 weeks.
Arms:
Sudapyridine arm
Bedaquiline
Two weeks of loading dose followed by twenty-two weeks of maintenance dose
Drug: Background regimen (BR) for RR-TB Background regimen (BR) for RR-TB selected according to WHO and local guidelines for up to 72 weeks.
Arms:
Bedaquiline arm
Size
450
Primary endpoint
The percentage of participants with Sputum Culture Conversion
Time frame: week 24
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}
Updated at
2024-01-05
1 organization
2 products
1 indication
Organization
Shanghai Jiatan PharmatechProduct
SudapyridineIndication
Rifampicin-resistant TuberculosisProduct
Bedaquiline