Phase 4 Tuberculosis Trial, Recruiting NCT06153069 Sponsor: Huashan Hospital Condition: Tuberculosis
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Phase 4 Tuberculosis Trial, Recruiting

NCT06153069
Recruiting Phase 4

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:

  • You are between 14 and 80 years old
  • You are male or female
  • You are willing to sign a consent form (or, if under 18, a parent/guardian can give consent on your behalf)
  • A sample from your airway or lungs (such as sputum, fluid, or tissue) has tested positive for tuberculosis (TB) bacteria
  • You have NOT had unexplained symptoms that could suggest TB (such as a cough lasting more than two weeks, night sweats, fever, or weight loss) in the three months before screening
  • If you are a woman who has not gone through menopause, you agree to use effective birth control during the treatment period

Who may not be able to join:

  • You have TB that has spread outside the lungs to other parts of the body
  • The TB damage in your lungs is very widespread — covering more than half the lungs or with large cavities (confirm with trial site)
  • Your TB bacteria are already known to be resistant to any of these medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones
  • Your liver is not functioning well enough, or you have liver cirrhosis (scarring of the liver)
  • Your blood counts are too low — specifically, low red blood cell levels (haemoglobin below 70g/L) or low platelet levels
  • Your kidneys are not working well enough (as measured by a specific kidney function test) (confirm with trial site)
  • You are known to be allergic or unable to tolerate any of the medicines used in this study
  • You are pregnant or currently breastfeeding
  • You have received TB treatment for more than one week in the past six months
  • You have a known history of epilepsy or uncontrolled diabetes
  • You are HIV-positive with a very low immune cell count (fewer than 100 CD4 cells/mm³)
  • You are unable to swallow or take medicines by mouth

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Wenhong Zhang, Dr., Huashan Hospital of Fudan University,Shanghai,China

Phone: (086)18817583793

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 4
Sponsor
Huashan Hospital
Registry
ClinicalTrials.gov
Start date
21 November 2025
Est. completion
1 November 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Favorable outcome rate in mITT pupulation

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