Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05294744

Enrollment

390

Registered

2022-03-24

Start date

2022-10-07

Completion date

2026-12-31

Last updated

2026-01-12

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

Conditions

Alcoholic Hepatitis

Brief summary

This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.

Detailed description

Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects. Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use. Clinical, randomized, controlled, multicenter, parallel and open trial.

Interventions

DRUGN-acetylcysteine

Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously. Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

This is an open trial.

Intervention model description

Clinical, randomized, controlled, multicenter, parallel and open trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Men and women. * Age from 18 to 75 years. * Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology. * Maddrey score\> = 32. * Acceptance of participation through written informed consent.

Exclusion criteria

* Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia. * Allergy or intolerance to N-acetylcysteine and / or corticosteroids. * Hepatocarcinoma. * Portal cavernomatosis. * Portal cavernomatosis. * Any disease whose life expectancy is less than 12 months. * Patients with nitroglycerin and / or carbamazepine-based treatments. * Patients with uncontrolled active infection. * Acute kidney disease with creatinine\> 2.5 mg / dL. * Uncontrolled upper gastrointestinal bleeding. * Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis). * Multiple organ failure or shock.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with all-cause mortality at 6 months.	6 months.	Main result variable.

Secondary

Measure	Time frame	Description
Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.	3 months	Security variable.

Countries

Spain

Contacts

Primary ContactAna Belén Fernández, Clinic

anabelen.fernandezlaso@osakidetza.eus945007000

Backup ContactInés Pérez, Coordinator

ines.perezfrancisco@osakidetza.eus945007000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026