Why might NAC (N-Acetylcysteine) reduce the risk of infection in alcoholic hepatitis?

The mechanism of action of N-ACetylcysteine for reducing the risk of Infection in Alcoholic Hepatitis - NACAH Version 1.1

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004522-17-GB

Enrollment

Registered

2015-01-27

Start date

2015-03-06

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic hepatitis

Interventions

Trade Name: NAC Product Name: Acetylcysteine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: N-Acetyl-L-Cysteine CAS Number: 616-91-1 Other descriptive name: NAC Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18 to 75 years • Clinical alcoholic hepatitis: o Serum bilirubin >80umol/L o History of alcohol excess (>80g/day male, >60g/day female) o Less than 4 weeks since admission to hospital o DF >32 o Informed 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

Exclusion criteria

Exclusion criteria: • Alcohol abstinence of >6 weeks prior to randomisation • Duration of jaundice >3 months • Other causes of liver disease including: o Evidence of viral hepatitis (hepatitis B or C) o Biliary obstruction o Hepatocellular 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

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the immunological mechanism by which NAC reduces 28 day susceptibility to infection in patients with alcoholic hepatitis?;Secondary Objective: Does 5 days of NAC therapy reduce susceptibility to infection at 3 months?;Primary end point(s): Monocyte oxidative burst improvement after 24 hours of NAC therapy.;Timepoint(s) of evaluation of this end point: 24 hours, 5 days, 28 days	—

Measure

Time frame

Main Objective: What is the immunological mechanism by which NAC reduces 28 day susceptibility to infection in patients with alcoholic hepatitis?;Secondary Objective: Does 5 days of NAC therapy reduce susceptibility to infection at 3 months?;Primary end point(s): Monocyte oxidative burst improvement after 24 hours of NAC therapy.;Timepoint(s) of evaluation of this end point: 24 hours, 5 days, 28 days

—

Secondary

Measure	Time frame
Secondary end point(s): Infection rate;Timepoint(s) of evaluation of this end point: Infection rate at 14 and 28 days and 3 months	—

Countries

United Kingdom

Contacts

Public ContactJoint Research Compliance Office

Imperial College London & Imperial College Healthcare NHS Trust

c.buicke@imperial.ac.uk02033110213

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026