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Recruiting NCT05294744

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

Trial Parameters

Condition Alcoholic Hepatitis
Sponsor Bioaraba Health Research Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 390
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-10-07
Completion 2026-07
Interventions
N-acetylcysteine

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.

Eligibility Criteria

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.

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