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To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).
Tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-TB drug was observed for 5-28%. Slow acetylator status in the N-acetyltransferase 2 (NAT2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (AT-DILI). We assessed the effect of N-acetylcysteine to prevent hepatitis from anti-TB drug in Thai population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC group | Experimental | Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C using NAC-long 1,200 mg/day for 8 weeks (NAC long group). Genetic test (acetylator status of NAT2), CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks. |
|
| Non-NAC group | No Intervention | Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C were using anti-TB alone (non-NAC group). Genetic test (Acetylator status of NAT2), CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N acetyl cysteine | Drug | N acetyl cysteine 1,200 mg/day for 8 weeks in NAC group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hepatitis at 8 weeks | To study efficacy of NAC to prevent anti-TB drug induced liver injury. Outcome was measured events of hepatitis occurred at 8 weeks, compared between NAC versus controlled group, presented by total number and percent. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hepatitis among NAT2 slow acetylator patients | To study efficacy of NAC to prevent anti-TB drug induced liver injury among NAT2 slow acetylator patients. Outcome was measured events of hepatitis occurred at 8 weeks among NAT2 slow acetylator patients compared between NAC versus controlled group, presented by total number and percent. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hepatitis at 2 weeks | Outcome was measured events of hepatitis occurred at 2 weeks, compared between NAC versus controlled group, presented by total number and percent. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels. | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kittichai Samaithongcharoen, MD | Contact | 0991494469 | pao_kitichai@hotmail.com | |
| Supot Supot, MD | Contact | 0819134336 | supotgi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Supot Nimanong, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
Patient data may be secure and not sharing
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D056486 | Chemical and Drug Induced Liver Injury |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C were randomized to using NAC-long 1,200 mg/day for 8 weeks (NAC long group) or using anti-TB alone (non-NAC group). Genetic test, CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks.
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| 8 weeks |
| Prevalence of hepatitis at 24 weeks |
Outcome was measured events of hepatitis occurred at 24 weeks, compared between NAC versus controlled group, presented by total number and percent. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels. |
| 24 weeks |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011041 | Poisoning |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |