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.

Study Overview

• Status: Recruiting
• Conditions: Alcoholic Hepatitis
• Intervention / Treatment: Drug: N-acetylcysteine

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.

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Belén Fernández, Clinic; Phone Number: 945007000; Email: anabelen.fernandezlaso@osakidetza.eus
• Study Contact Backup: Name: Inés Pérez, Coordinator; Phone Number: 945007000; Email: ines.perezfrancisco@osakidetza.eus

Study Locations

• Spain
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01009
      • Recruiting
      • Ana Belén Fernández Laso
      • Contact: Ana Belén Fernández, Clinic; Phone Number: 945007000; Email: anabelen.fernandezlaso@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Corticosteroids; Corticosteroids following Standard Clinical Practice	Drug: N-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.
Experimental: Corticosteroids + N-acetylcysteine; Corticosteroids following Standard Clinical Practice plus N-acetylcisteine	Drug: N-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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bioaraba Health Research Institute
• Investigators: Principal Investigator: Ana Belén Fernández, Clinic, HUA

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Hepatitis; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Hepatitis, Alcoholic; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Amino Acids; Cysteine; Amino Acids, Sulfur; Acetylcysteine
• Other Study ID Numbers: CONACHAA; 2020-004549-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no a plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No