Status:
RECRUITING
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Lead Sponsor:
Mahidol University
Conditions:
Tuberculosis (TB)
Isoniazid Toxicity
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 im...
Detailed Description
Tuberculosis (TB) is a significant public health problem in Thailand and globally, especially in hot climates. TB infection is commonly found in the lungs, but it can also affect other important organ...
Eligibility Criteria
Inclusion
- 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
- 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 the upper limit of normal (48 U/L), ALT \> 1.5 times the 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).
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06484530
Start Date
March 12 2024
End Date
September 18 2024
Last Update
July 3 2024
Active Locations (1)
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1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand, 10700