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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
JDB0131 100mg
DrugBedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. JDB0131 (J): 100 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd.
JDB0131 200mg
DrugBedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. JDB0131 (J): 200 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd.
Delamanid (D)
DrugBedaquiline (B): For the first 2 weeks, 400 mg qd; then adjust to 200 mg tiw. Delamanid (D): 100 mg bid. Linezolid (L): 600 mg qd. Levofloxacin (Lfx): According to body weight, patients ≤50 kg, 750 mg qd; patients \>50 kg, 1000 mg qd. Moxifloxacin (M): 400 mg qd. Clofazimine (C): 100 mg qd.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group A: BJLLfx(M)/CExperimental treatment 1 intervention
Group B: Group B: BJLLfx(M)/CExperimental treatment 1 intervention
Group C: Group C: BDLLfx/CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Patients with Sputum Culture Conversion (SCC)
SCC was defined as a patient without SCC at baseline who subsequently met the definition of SCC. A patient was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart and had no further sputum cultures that were positive for growth within the specified time frame. Patients who have sputum cultures that were positive during treatment but only converted to negative at the end of treatment were also counted as negative.
Time frame
During the 8-week treatment period and after treatmentSecondary outcomes
1
Time to Sputum Culture Conversion (SCC)
SCC was defined as a patient without SCC at baseline who subsequently met the definition of SCC. A patient was classified as having achieved SCC if he/she achieved 2 consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart and had no further sputum cultures that were positive for growth within the specified time frame. Patients who have sputum cultures that were positive during treatment but only converted to negative at the end of treatment were also counted as negative. Time to SCC was defined as the earliest time of two consecutive sputum cultures negative for growth, that is, the time (specimen collection time) of the first sputum culture negative for growth among two consecutive sputum cultures negative for growth of mycobacterium tuberculosis (MTB) at least 7 days apart was taken as the negative conversion time, expressed in days.
Time frame
During the 8-week treatment period and after treatment2
Time to positivity (TTP)
Time-to-positivity (TTP) is defined as the length of time from the beginning of culture incubation to the positive detection of mycobacterium tuberculosis growth.
Time frame
During the 8-week treatment period and after treatment3
Number of Participants With Clinically Significant Abnormality in Vital Signs
Vital signs included body temperature (degree Celsius), heart rate \[beats/minute (bpm)\], breathe \[times/minute (tpm)\], systolic and diastolic blood pressure \[millimetre of mercury (mm Hg)\].
Time frame
During the 8-week treatment period4
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
The clinically significant abnormal ECG values including ventricular rate outlier, PR outlier, QRS outlier, QT outlier and QTcF outlier.
Time frame
During the 8-week treatment periodSponsors and contacts
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Source ClinicalTrials.gov