Phase 3 Tuberculosis Trial, Recruiting NCT05824871 Sponsor: Shanghai Jiatan Pharmatech Co., Ltd Condition: Tuberculosis
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Phase 3 Tuberculosis Trial, Recruiting

NCT05824871
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your body weight is between 40kg and 90kg, and your body mass index (BMI) is between 15.0 and 28.0 (a measure of weight relative to height)
  • You have been diagnosed with tuberculosis (TB) that has been shown through testing to be resistant to at least the drug rifampicin, with test results from within the last 3 months
  • Your sputum (mucus coughed up from the lungs) test has come back positive for TB bacteria at a certain level (1+ or higher)
  • You are willing to stop all current TB medications and go through a 7-day "washout period" before starting the trial
  • If you are a woman, you are not pregnant or breastfeeding, and you agree to use contraception throughout the treatment; or if you are a man, your partner agrees to use contraception throughout the treatment

Who may not be able to join:

  • You are allergic to any of the study drugs or their ingredients
  • You have a history of alcohol dependence or drug abuse
  • Your TB has spread through the bloodstream or to parts of the body outside the lungs
  • Pre-screening tests showed your TB is resistant to more than 4 of the 8 TB drugs being used in this study
  • You have previously taken the drug Bedaquiline
  • You are HIV-positive
  • Your recent lab (blood or urine) tests show significant abnormalities
  • You have a history of a specific serious irregular heartbeat called torsades de pointes, or heart-related risk factors for it
  • Your heart's electrical activity (measured by an ECG) shows a reading called QTcF above 450ms, or you have other significant heart rhythm problems that may need treatment
  • You have a documented heart or cardiovascular disease
  • You have significant nerve damage (peripheral neuropathy) that is severe or likely to get worse, or you have inflammation of the optic nerve (the nerve connecting your eye to your brain)
  • You have any serious disease affecting the heart, kidneys, liver, blood, immune system, hormones, or joints, or you have been diagnosed with cancer

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Naihui Chu, Ph.D, Beijing Chest Hospital affiliated to Capital Medical University

Phone: 010-89509312

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Shanghai Jiatan Pharmatech Co., Ltd
Registry
ClinicalTrials.gov
Start date
2 September 2022
Est. completion
22 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Sputum Culture Conversion Rate at Week 24

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov