Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05294744

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

Led by Bioaraba Health Research Institute · Updated on 2026-01-12

390

Participants Needed

1

Research Sites

216 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Age from 18 to 75 years
  • Diagnosed with acute alcoholic hepatitis according to AASLD criteria or liver histology
  • Maddrey score greater than or equal to 32
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Jaundice caused by acute hepatitis, positive HIV serology, biliary-pancreatic disease, or hemolytic anemia
  • Allergy or intolerance to N-acetylcysteine or corticosteroids
  • Presence of hepatocarcinoma
  • Portal cavernomatosis
  • Any illness with life expectancy under 12 months
  • Treatment with nitroglycerin or carbamazepine
  • Uncontrolled active infection
  • Acute kidney disease with creatinine over 2.5 mg/dL
  • Uncontrolled upper gastrointestinal bleeding
  • Other uncontrolled diseases including HBV, HCV, HIV, tuberculosis, drug-induced liver injury, hepatocellular carcinoma, or acute pancreatitis
  • Multiple organ failure or shock

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ana Belén Fernández Laso

Vitoria-Gasteiz, Álava, Spain, 01009

Actively Recruiting

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Research Team

A

Ana Belén Fernández, Clinic

CONTACT

I

Inés Pérez, Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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