Actively Recruiting
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Led by Bioaraba Health Research Institute · Updated on 2026-01-12
390
Participants Needed
1
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women
- Age from 18 to 75 years
- Diagnosed with acute alcoholic hepatitis according to AASLD criteria or liver histology
- Maddrey score greater than or equal to 32
- Provided written informed consent to participate
You will not qualify if you...
- Jaundice caused by acute hepatitis, positive HIV serology, biliary-pancreatic disease, or hemolytic anemia
- Allergy or intolerance to N-acetylcysteine or corticosteroids
- Presence of hepatocarcinoma
- Portal cavernomatosis
- Any illness with life expectancy under 12 months
- Treatment with nitroglycerin or carbamazepine
- Uncontrolled active infection
- Acute kidney disease with creatinine over 2.5 mg/dL
- Uncontrolled upper gastrointestinal bleeding
- Other uncontrolled diseases including HBV, HCV, HIV, tuberculosis, drug-induced liver injury, hepatocellular carcinoma, or acute pancreatitis
- Multiple organ failure or shock
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ana Belén Fernández Laso
Vitoria-Gasteiz, Álava, Spain, 01009
Actively Recruiting
Research Team
A
Ana Belén Fernández, Clinic
CONTACT
I
Inés Pérez, Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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