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

NCT05294744 | Recruiting

• 2 other identifiers: CONACHAA2020-004549-35
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (1)

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

  Main result variable.

  6 months.

Secondary Outcomes (1)

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

  3 months

Study Arms (2)

Corticosteroids

ACTIVE COMPARATOR

Corticosteroids following Standard Clinical Practice

Drug: N-acetylcysteine

Corticosteroids + N-acetylcysteine

EXPERIMENTAL

Corticosteroids following Standard Clinical Practice plus N-acetylcisteine

Drug: N-acetylcysteine

Interventions

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.

Corticosteroids; Corticosteroids + N-acetylcysteine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioaraba Health Research Institute: lead

Study Sites (1)

Ana Belén Fernández Laso

Vitoria-Gasteiz, Álava, 01009, Spain

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ana Belén Fernández, Clinic

  HUA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Belén Fernández, Clinic

CONTACT

945007000; anabelen.fernandezlaso@osakidetza.eus

Inés Pérez, Coordinator

CONTACT

945007000; ines.perezfrancisco@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical, randomized, controlled, multicenter, parallel and open trial.

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: March 24, 2022
• Study Start: October 7, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)