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Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081

NCT04608955 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-09-11

No results posted yet for this study

Summary

This is a multi-center, randomized, parallel, open-label, positive-controlled Phase 2 clinical trial, which aims to evaluate the early bactericidal activity, safety and tolerability of WX-081 in patients with drug-naive\&susceptible and drug-resistant tuberculosis. Also the efficacy of WX-081 will be explored in participants with drug-resistant tuberculosis.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

WX-081

WX-081 is not licensed yet. WX-081 will be used in arms A, B, C, WX-081+MBT.

DRUG

Bedaquiline

This licensed drug will be used in arm F as positive comparator.

DRUG

Standard treatment

Standard treatment will be used in arm D as positive comparator, according to the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.

DRUG

Multi-drug background treatment (MBT)

MBT will be used in arm E, F as background treatment. The drugs used in MBT are all licensed drugs, and the treatment complies with the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.

Sponsors & Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Song AiYun, MD · Shang hai Jiatan Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2022-04-13
Completion
2022-04-13

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04608955 on ClinicalTrials.gov