Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484530
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-04-03
Brief Title:
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 organs such as lymph nodes pleura abdomen musculoskeletal system urinary tract and nervous system The current standard treatment regimen for TB consists of a combination of drugs isoniazid rifampicin pyrazinamide and ethambutol used for new TB patients who have not been treated before or have received less than 1 month of treatment A major challenge in TB treatment is that patients must take multiple drugs continuously for at least 6 months with common side effects including skin rash dizziness hepatitis nausea vomiting and abdominal pain often occurring within the first 2 months of treatment Hepatotoxicity from anti-TB drugs is a common side effect occurring in 20-60 of patients mostly within the first 2 weeks to 2 months of starting treatment Isoniazid rifampicin and pyrazinamide are the drugs most commonly associated with hepatotoxicity typically causing hepatocellular injury of varying severity NAT2 slow acetylator phenotype individuals are at higher risk Studies in Thailand have found a high prevalence 25-30 of NAT2 slow acetylators among Thai people Preventing hepatotoxicity from anti-TB drugs is crucial especially for high-risk patients although clear guidelines are lacking Previous studies have shown that administering N-acetylcysteine NAC an antioxidant can reduce hepatotoxicity particularly in slow acetylators A recent controlled study by Kittichai Samaithongcharoen and colleagues demonstrated the significant efficacy of NAC in preventing hepatotoxicity in slow acetylators receiving standard TB treatment with no cases of hepatotoxicity compared to a 50 incidence in the control group Further research is needed to explore the effectiveness of NAC administration for preventing hepatotoxicity from anti-TB drugs based on NAT2 genotype testing compared to current standard TB treatment protocols
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None