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New treatment option for Tuberculosis
Official title A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
ClinicalTrials.gov ID: NCT07170800
What this study is testing
What is JDB0131 100mg?
JDB0131 100mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for tuberculosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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...
- Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)
- Patients who are currently taking anti-tuberculosis treatment or using drugs with anti-tuberculosis effects agree to stop all anti-tuberculosis drug...
You likely can't join if
- 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...
- History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or...
- Anyone with any of the following cardiovascular diseases or other conditions within 6 months before enrollment:
- Myocardial infarction;
See the full eligibility criteria
Who can join
- 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...
- Sputum acid-fast bacilli smear is positive (≥2+ once or 1+ twice at least)
- Patients who are currently taking anti-tuberculosis treatment or using drugs with anti-tuberculosis effects agree to stop all anti-tuberculosis drug treatment and complete a 7-day washout period
- Women of reproductive age must agree to use highly effective contraceptive measures throughout the study and for at least 6 months after discontinuation of the drug. Male participants whose partners are women of...
- Fully understand the purpose and requirements of this trial, voluntarily sign the written informed consent and agree to abide by the relevant provisions of the informed consent
What rules you out
- 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...
- History of torsades de pointes or risk factors, including a personal or family history of long QT syndrome (LQTS), persistent hypothyroidism, or bradycardia
- Anyone with any of the following cardiovascular diseases or other conditions within 6 months before enrollment:
- Myocardial infarction;
- Heart surgery or coronary revascularization (coronary artery bypass grafting/percutaneous transluminal coronary angioplasty);
- Unstable angina;
- Congestive heart failure (New York Heart Association functional class III or IV);
- Transient ischemic attack or severe cerebrovascular disease.
- Peripheral neuropathy CTCAE grade 3 or 4; Grade 1 or 2 peripheral neuropathy that the investigator judges may progress/worsen during the study; Patients with optic neuritis
- History of gastrointestinal surgery or resection that may affect the absorption and/or excretion of oral medications
- Patients who are considered by the investigator to be unsuitable for this trial due to unstable or severe cardiovascular, renal, hepatic, blood, tumor, endocrine metabolic, psychiatric or rheumatic diseases
- History of alcohol dependence or drug abuse within 6 months before screening, the investigator believes that it may affect the safety of the participants and affect the trial compliance
- Patients who have used other clinical trial investigational drugs within 3 months before administration
- Concomitant take drugs that cause bone marrow suppression
- Concomitant take serotonin reuptake inhibitors, tricyclic antidepressants, serotonin, serotonin receptor agonists, and other drugs
- Concomitant take drugs that prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, etc.
- Chronic systemic corticosteroid therapy, cumulative take for more than 4 weeks within 3 months before enrollment
- Allergic to any investigational drug or related substance as confirmed by the researcher's clinical judgment
- Women who have a positive pregnancy test during screening or are breastfeeding
- Patients with hepatitis B virus (HBV) positive results (HBsAg, HBeAg, and HBcAb); positive hepatitis C virus (HCV) antibodies and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \>3 times the...
- Laboratory tests show any of the following:
- Hemoglobin \< 80 g/L;
- platelets \< 75 ✕ 109 /L;
- Aspartate aminotransferase (AST) \> 3 times the upper limit of normal;
- Alanine aminotransferase (ALT) \> 3 times the upper limit of normal;
- Serum total bilirubin (TBIL) \> 2 times the upper limit of normal;
- Serum creatinine (Cr) \> 1.5 times the upper limit of normal;
- Serum amylase \> 2 times the upper limit of normal.
- The following abnormalities were found in the electrocardiogram (ECG):
- At least twice QTcF intervals \> 450 ms (male) or \> 470 ms (female);
- Pathological Q waves (defined as \>40 ms or deep \>0.4-0.5mV);
- ECG suggests preexcitation syndrome;
- ECG suggests left bundle branch block or right bundle branch block; or second or third degree heart block;
- Intraventricular conduction delay with QRS duration \>120ms;
- Bradycardia with a sinus rate \< 50 bpm.
- In the investigator's judgment, any condition that affects the subject's compliance with the study protocol, or any serious medical or psychological condition that may affect the interpretation of how well it works and...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Jinan, Shandong, China
- Chengdu, Sichuan, China
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Jinan, Shandong, China; Chengdu, Sichuan, China; Beijing, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.