A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets

Recruiting Phase 2 Interventional Study
Tuberculosis Multidrug Resistant Pulmonary Tuberculosis Rifampicin-resistant Tuberculosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
14 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
WestVac Biopharma Co., Ltd. · Industry
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About This Trial
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age: 14 years through 65 years of age, male or female * Weight: 40kg ≤ weight ≤ 90kg * Patients with clinically confirmed pulmonary tuberculosis, Drug Susceptibility Testing (DST) results confirmed to be at least rifampicin-resistant, molecular or phenotypic DST results within…
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