Actively Recruiting
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Led by Mahidol University · Updated on 2024-07-03
116
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 20-60% of patients, is commonly linked to isoniazid, rifampicin, and pyrazinamide. Slow acetylators of the NAT2 gene are particularly susceptible. Previous research suggests N-acetylcysteine (NAC) may mitigate hepatotoxicity, especially among slow acetylators. A recent study by Kittichai Samaithongcharoen and team showed that NAC reduced hepatotoxicity incidence significantly among slow acetylators. This underscores the potential of NAC in preventing drug-induced hepatotoxicity in TB treatment, warranting further investigation against standard treatment protocols.
CONDITIONS
Official Title
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 - 80 years old.
- Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary).
- Receiving standard anti-tuberculosis medication according to standard regimens (2HRZE/4HR, 2HRE/7HR).
- Willing to participate in the research
You will not qualify if you...
- Infected with HIV.
- Severe liver dysfunction classified as Child-Pugh B or C.
- Chronic untreated liver diseases such as hepatitis B or C, alcoholic liver disease.
- Abnormal liver function tests including AST > 1.5 times upper limit of normal (48 U/L), ALT > 1.5 times upper limit of normal (55 U/L), ALP > upper limit of normal (110 U/L), Total bilirubin > upper limit of normal (1.2 mg/dL).
- Diagnosed with cancer.
- History of allergy to N-acetylcysteine (NAC).
- Pregnant or breastfeeding.
- Severe comorbidities such as CKD stage 4-5, chronic heart failure, severe pulmonary diseases (COPD, bronchiectasis).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
Research Team
P
Pongpot Namasae
CONTACT
S
Supot Nimanong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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