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NCT Number: NCT05294744

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ana Belén Fernández Laso

Vitoria-Gasteiz, Álava, 01009, Spain

Location status: Recruiting

Location contact

Ana Belén Fernández, Clinic

CONTACT

[email protected]

945007000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine

Drug

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.

Primary outcomes

  1. Number of Participants with all-cause mortality at 6 months.

    Time frame: 6 months.

    Main result variable.

Secondary outcomes

  1. Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.

    Time frame: 3 months

    Security variable.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Belén Fernández, Clinic

CONTACT

[email protected]

945007000

Inés Pérez, Coordinator

CONTACT

[email protected]

945007000

Sponsors and collaborators

Lead sponsor

Bioaraba Health Research Institute

Network

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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