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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Page 1 of 1 (2 locations)

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