A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorWestVac Biopharma Co., Ltd.
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-resistant) tuberculosis for 8 weeks.
Eligibility criteria
Qualifiers
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 3 months before enrollment can be received
Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)
Disqualifiers
Those who cannot take delamanid, bedaquiline, or linezolid for various reasons
Take delamanid, bedaquiline, or linezolid for more than 1 month (can be enrolled if evidence of no resistance to the above drugs is provided)
Hematogenously disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator; or patients with pulmonary tuberculosis who are assessed by the investigator to be likely to require surgical treatment within 8 weeks
History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia
Trial design
Treatments tested in this trial
- JDB0131 100mg
- JDB0131 200mg
- Delamanid (D)
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov