Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Recruiting
Phase 4
Interventional Study
Tuberculosis (TB)
Isoniazid Toxicity
Rifampicin Toxicity
Pyrazinamide Adverse Reaction
Ethambutol Toxicity
NAT2 Slow Acetylator Status
NAT2 Rapid Acetylator Status
NAT2 Polymorphism
N-Acetylcysteine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 116 (estimated)
- Sponsor
- Mahidol University · Other
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About This Trial
Tuberculosis (TB) remains a significant public health concern in Thailand and globally, especially in tropical regions, with pulmonary TB being predominant. Besides affecting the lungs, TB can also impact extrapulmonary organs. Standard TB treatment involves a combination of drugs administered for at least 6 months, but it can cause adverse effects such as hepatitis. Hepatotoxicity, occurring in 2…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients aged 18 - 80 years old.
* Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary).
* Received standard anti-tuberculosis medication according to standard regimens (2HRZE/4HR, 2HRE/7HR).
* Willing to participate in the research
Exclusion Criteria:
*…
Contacts