Clinical Trials Logo

Clinical Trial Summary

We will conduct a randomized placebo controlled trial to determine whether administration of intravenous (IV) NAC to participants with TB DIH, in dosages similar to that used in paracetamol poisoning, can improve recovery from hepatotoxicity.


Clinical Trial Description

South Africa has a huge tuberculosis (TB) disease burden, with 948 per 100 000 people diagnosed with TB in 2008. TB drug induced hepatitis (DIH) is a common adverse effect of TB therapy that causes significant patient morbidity and prolonged hospital stays. N-Acetylcysteine (NAC) has been extensively studied and used for many years in the treatment of paracetamol-induced hepatotoxicity, with good evidence of efficacy and safety. NAC has also been used in other forms of liver injury and drug toxicity. It has not previously been used in the management of TB DIH.

We will screen all patients with clinical hepatitis on TB treatment admitted to New Somerset and Groote Schuur hospitals and aim to recruit 100 participants over 3 years. We will randomise 50 participants to receive an IV loading dose of 150mg/kg of NAC over 60 minutes followed by 50mg/kg IV over 4 hours by continuous infusion and finally 100mg/kg IV over 16 hours. Fifty participants will be randomised to receive placebo. The primary outcome will be time to normalisation of liver function (ALT<100). We will also determine the effect of NAC on duration of hospitalization, rate of recovery from liver failure, all cause mortality, and describe adverse effects of IV NAC in this patient population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02182167
Study type Interventional
Source University of Cape Town
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 2014
Completion date February 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05517668 - Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose Phase 2
Recruiting NCT05060289 - A Prognostic Model for Drug-induced Liver Injury in China
Completed NCT03092817 - Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial) Phase 3
Recruiting NCT03211208 - Assessing Antibiotic Induced Liver Injury for Stratification of Tuberculosis Patients
Not yet recruiting NCT02061826 - Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA) N/A
Completed NCT03665402 - A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status N/A
Not yet recruiting NCT03091218 - Surveillance for Early Liver Injuries Caused by Runzao Zhiyang Capsule. N/A
Not yet recruiting NCT03091556 - Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill. N/A
Not yet recruiting NCT03091244 - Surveillance for Early Liver Injuries Caused by Xianlin Gubao Capsule. N/A
Not yet recruiting NCT03091608 - Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule N/A
Not yet recruiting NCT03060252 - Surveillance for Early Liver Injuries Caused by Zhuanggu Guanjie Pill N/A
Completed NCT02407964 - A Retrospective Study on Drug Induced Liver Injury in China N/A
Active, not recruiting NCT05144217 - Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo Phase 2/Phase 3
Completed NCT01705041 - Preliminary Evaluation of a Point-Of-Care Liver Function Test N/A
Recruiting NCT02086708 - Ultrasound Method to Measure Fibrosis of the Liver in Children N/A
Recruiting NCT05465642 - Alterations of Gut Microbiota and Serum Biochemical Markers in DILI Patients
Completed NCT01434173 - Risk of Acute Liver Injury in Users of Antimicrobials N/A
Completed NCT05532345 - Discrimination of DILI and AIH by Artificial Intelligence
Completed NCT03602703 - Immune Responses in Hepatocellular Carcinoma Patients After Treatment With Direct Acting Antiviral Drugs
Active, not recruiting NCT03100786 - Leukotriene A4 Hydrolase Stratified Trial of Adjunctive Corticosteroids for HIV-uninfected Adults With Tuberculous Meningitis Phase 3