CompletedPhase 2/3

A Trial Of Intravenous N-Acetylcysteine In The Management Of Antituberculous Drug-Induced Hepatitis

South Africa102 participantsStarted 2014-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults \> 18 years old * Diagnosed with pulmonary or extrapulmonary tuberculosis based on symptoms, radiological features and/or laboratory evidence. * On first line antituberculous therapy * Diagnosed with TB DIH Exclusion Criteria: * Patients with a diagnosis of acute viral hepatitis based on a positive anti-HAV, IgM, anti- HBcIgM, or confirmed hepatitis C infection * Patients known to be asthmatic

What they're measuring

ALT normalisation

Timeframe: up to 8 weeks

Trial details

NCT IDNCT02182167

SponsorUniversity of Cape Town

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02

View on ClinicalTrials.gov More Drug-Induced Liver Injury trials