Why might NAC (N-Acetylcysteine) reduce the risk of infection in alcoholic hepatitis?
- Conditions
- Alcoholic hepatitisTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2014-004522-17-GB
- Lead Sponsor
- Imperial College London & Imperial College Healthcare NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 42
Aged 18 to 75 years
•Clinical alcoholic hepatitis:
oSerum bilirubin >80umol/L
oHistory of alcohol excess (>80g/day male, >60g/day female)
oLess than 4 weeks since admission to hospital
oDF >32
oInformed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
•Alcohol abstinence of >6 weeks prior to randomisation
•Duration of jaundice >3 months
•Other causes of liver disease including:
oEvidence of viral hepatitis (hepatitis B or C)
oBiliary obstruction
oHepatocellular carcinoma
•Evidence of current malignancy (except non-melanotic skin cancer)
•Previous entry into the study,
•Patients with known hypersensitivity or previous anaphylactoid reactions to NAC
•Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method