[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nat2-polymorphism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nat2-polymorphism":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100553318","phase-4-gene-guided-n-acetyl-cysteine-for-prophylaxis-of-anti-tuberculous-drug--induced-hepatitis-100553318",false,"NCT06484530","Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis","Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 - 80 years old.\n* Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary).\n* Received standard anti-tuberculosis medication according to standard regimens (2HRZE\u002F4HR, 2HRE\u002F7HR).\n* Willing to participate in the research\n\nExclusion Criteria:\n\n* Infected with HIV.\n* Severe liver dysfunction classified as Child-Pugh B or C.\n* Chronic untreated liver diseases such as hepatitis B or C, alcoholic liver disease.\n* Abnormal liver function tests including AST \\> 1.5 times the upper limit of normal (48 U\u002FL), ALT \\> 1.5 times the upper limit of normal (55 U\u002FL), ALP \\> upper limit of normal (110 U\u002FL), Total bilirubin \\> upper limit of normal (1.2 mg\u002FdL).\n* Diagnosed with cancer.\n* History of allergy to N-acetylcysteine (NAC).\n* Pregnant or breastfeeding.\n* Severe comorbidities such as CKD stage 4-5, chronic heart failure, severe pulmonary diseases (COPD, bronchiectasis).","ALL","18 Years","80 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","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.",[27,28,29,30,31,32,33,34,35],"Tuberculosis (TB)","Isoniazid Toxicity","Rifampicin Toxicity","Pyrazinamide Adverse Reaction","Ethambutol Toxicity","NAT2 Slow Acetylator Status","NAT2 Rapid Acetylator Status","NAT2 Polymorphism","N-Acetylcysteine",[27,28,29,30,31,32,33,34,35],"RECRUITING","2024-07-01",{"date":40,"type":41},"2024-07-03","ACTUAL",{"date":43,"type":41},"2024-03-12",{"date":45,"type":21},"2024-09-18",{"name":47,"class":48},"Mahidol University","OTHER"]