drugset / Trial / NCT02889757

The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)

NCT02889757

Phase 4 Unknown 400 enrolled Far Eastern Memorial Hospital
RandomizedFactorialDouble-blindPrevention

Summary

Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However, there are few published data and large sample sizes regarding the protective effect of NAC against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge. Therefore, the investigators designed a clinical trial with the aim to see whether NAC could protect against anti-TB drug-induced hepatotoxicity (DIH)

Timeline

Start
2017-01
Primary completion
2018-12
Completion
2019-06

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 1200 mg
Subject N-acetylcysteine Small molecule 2400 mg