Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT03069300
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03069300
Study Brief:
Protocol Section:
NCT03069300