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WISH: Sudapyridine (WX-081) in RR-TB Patients

Sponsor
Shanghai Jiatan Pharmatech Co., Ltd (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05824871
Collaborator
(none)
450
Enrollment
1
Location
2
Arms
27.7
Anticipated Duration (Months)
16.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a multicenter, randomized, double-blind, positive-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with background medication (BR) in patients with rifampicin-resistant tuberculosis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Sep 2, 2022
Anticipated Primary Completion Date :
Dec 22, 2023
Anticipated Study Completion Date :
Dec 22, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sudapyridine arm

Drug: 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.
Active Comparator: Bedaquiline arm

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. The percentage of participants with Sputum Culture Conversion [Time frame: week 24]

    Sputum culture conversion is defined as having two consecutive negative cultures at least 28 days apart, not followed by a confirmed positive culture during the considered time period

Secondary Outcome Measures

  1. The Time to Sputum Culture Conversion [Time Frame: Week 24]

    Sputum culture conversion is defined as having two consecutive negative cultures at least 28 days apart, not followed by a confirmed positive culture during the considered time period

  2. The percentage of participants with Sputum Culture Conversion and treatment success [Time Frame: Week 72]

    The clinical effectiveness of this study was evaluated based on treatment success, which included both treatment completion and the achievement of favorable outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chest Hospital affiliated to Capital Medical University Beijing Beijing China 101149

Sponsors and Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

Investigators

  • Principal Investigator: Naihui Chu, Ph.D, Beijing Chest Hospital affiliated to Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Jiatan Pharmatech Co., Ltd
ClinicalTrials.gov Identifier:
NCT05824871
Other Study ID Numbers:
  • JYP0081M301
First Posted:
Apr 24, 2023
Last Update Posted:
Apr 24, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tuberculosis
Bedaquiline

Study Results

No Results Posted as of Apr 24, 2023