A Phase 4 interventional study of Acteylcysteine in Protective Effect in TB-DIH and TB-DIH Means: Drug Induced Liver Function Abnormalities, sponsored by Far Eastern Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-09-13.
Sponsored by Far Eastern Memorial Hospital · Phase 4, Interventional, and Prevention
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)
Isoniazid (INH), rifampicin (RIF), and pyrazinamide (PZA), the first-line drugs used for tuberculosis (TB) chemotherapy, are associated with hepatotoxicity. A high rate of hepatotoxicity has been reported in some developing countries compared with advanced countries with a similar dose schedule. Sharifzadeh et al. reported an incidence of 27.7% in Iran. The reasons for this higher rate of hepatotoxicity are not completely clear. Ethnic variations, advanced age, female sex, alcoholism, underlying liver disease, acetylator phenotype, hepatitis B and C virus, HIV infection, extensive pulmonary parenchymal disease, and hypoalbuminemia have been observed to be the risk factors for the development of drug-induced hepatotoxicity (DIH) because of anti-TB treatment.
The mechanism of DIH induced by anti-TB treatment is not yet fully understood. Sodhi et al. proposed oxidative stress as one of the likely mechanisms for INH-RIF-induced hepatic injury. It is well established that by augmenting a cellular antioxidative defense system, especially nonprotein thiols, that is, glutathione (GSH), cells can be protected against oxidative injuries produced by various drugs and chemicals.
The study will be performed with randomized trial for assessment and protective effects over liver function in patients receiving anti-TB agents and using NAC.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's planned enrollment of 400 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
patients with add NAC (600) 1# bid use per day during the study period
Drug: Acteylcysteine
patients with add NAC (600) 2# bid use per day during the study period
Drug: Acteylcysteine
patients with add NAC (600) 0# (placebo) use per day during the study period
Drug: Acteylcysteine
randomized into three arms
the incidence of DIH
the rate for
Time frame: during the 6 months treatment
the incidence for other side effects
side effects including GI upset, blurred vision, neuropathy, renal organ damage
Time frame: 6 months
Plan to share: No
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Far Eastern Memorial Hospital