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

Primary Purpose

Rifampicin-resistant Tuberculosis

Status
Enrolling by invitation
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sudapyridine
Bedaquiline
Sponsored by
Shanghai Jiatan Pharmatech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rifampicin-resistant Tuberculosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chest Hospital affiliated to Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sudapyridine arm

Bedaquiline arm

Arm Description

Outcomes

Primary Outcome Measures

The percentage of participants with Sputum Culture Conversion
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

The Time to Sputum Culture Conversion
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
The percentage of participants with Sputum Culture Conversion and treatment success
The clinical effectiveness of this study was evaluated based on treatment success, which included both treatment completion and the achievement of favorable outcomes.

Full Information

First Posted
April 10, 2023
Last Updated
April 21, 2023
Sponsor
Shanghai Jiatan Pharmatech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05824871
Brief Title
Sudapyridine (WX-081) in RR-TB Patients
Acronym
WISH
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Jiatan Pharmatech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rifampicin-resistant Tuberculosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sudapyridine arm
Arm Type
Experimental
Arm Title
Bedaquiline arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sudapyridine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bedaquiline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of participants with Sputum Culture Conversion
Description
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
Time Frame
Time frame: week 24
Secondary Outcome Measure Information:
Title
The Time to Sputum Culture Conversion
Description
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
Time Frame
Time Frame: Week 24
Title
The percentage of participants with Sputum Culture Conversion and treatment success
Description
The clinical effectiveness of this study was evaluated based on treatment success, which included both treatment completion and the achievement of favorable outcomes.
Time Frame
Time Frame: Week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naihui Chu, Ph.D
Organizational Affiliation
Beijing Chest Hospital affiliated to Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chest Hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Sudapyridine (WX-081) in RR-TB Patients

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