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Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
RECRUITINGN/ASponsored by Bioaraba Health Research Institute
Actively Recruiting
PhaseN/A
SponsorBioaraba Health Research Institute
Started2022-10-07
Est. completion2026-07
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05294744
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
Age: 18 Years – 75 YearsHealthy volunteers accepted
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.
Conditions2
Alcoholic HepatitisLiver Disease
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Actively Recruiting
PhaseN/A
SponsorBioaraba Health Research Institute
Started2022-10-07
Est. completion2026-07
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05294744