Using N-acetylcysteine to lower infection and death rates in alcoholic hepatitis
The Mechanism of Action of N-acetylcysteine for Reducing the Risk of Infection in Alcoholic Hepatitis
This study is testing if adding N-acetylcysteine to standard treatment can help people with severe alcoholic hepatitis lower their risk of infections and improve survival rates.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03069300 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of N-acetylcysteine (NAC) on patients with severe alcoholic hepatitis, particularly focusing on its potential to reduce infection rates and mortality. The study is a randomized controlled trial that aims to determine if NAC improves the oxidative burst function of phagocytes, thereby enhancing the immune response in these patients. Participants will receive NAC in addition to standard treatment with prednisolone, and outcomes will be compared to those receiving prednisolone alone. The trial is designed to provide insights into the mechanisms by which NAC may confer protective benefits in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinical alcoholic hepatitis and specific laboratory criteria indicating severe disease.
Not a fit: Patients who have been abstinent from alcohol for more than six weeks or have other underlying liver diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce infection rates and mortality in patients suffering from alcoholic hepatitis.
How similar studies have performed: Previous studies have shown promising results with NAC in reducing mortality in similar patient populations, suggesting a potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Clinical alcoholic hepatitis: * Serum bilirubin \>80umol/L * History of alcohol excess (\>80g/day male, \>60g/day female) * Less than 4 weeks since admission to hospital * Maddrey's discriminant function (DF) \>32 * Informed consent Exclusion Criteria: * Alcohol abstinence of \>6 weeks prior to randomisation * Duration of jaundice \>3 months * Other causes of liver disease including: * Evidence of viral hepatitis (hepatitis B or C) * Biliary obstruction * Hepatocellular carcinoma * Evidence of current malignancy (except non-melanotic skin cancer) * Previous entry into the study * Patients with known hypersensitivity or previous reactions to NAC * Pregnant or lactating women
Where this trial is running
London
- St Mary's Hospital, Imperial College — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark Thursz, MD — Imperial College London
- Study coordinator: Nikhil Vergis, PhD
- Email: nvergis@ic.ac.uk
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.