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

Not Applicable

• Conditions: Alcoholic Hepatitis
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT05294744
• Lead Sponsor: Bioaraba Health Research Institute

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.

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 Timeline

• Study First Submitted: 2021-07-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-03-24
• Last Update Posted: 2022-03-24
• Study Start: 2022-04
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 390

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroids	N-acetylcysteine	Corticosteroids following Standard Clinical Practice
Corticosteroids + N-acetylcysteine	N-acetylcysteine	Corticosteroids following Standard Clinical Practice plus N-acetylcisteine

Primary Outcome Measures

Name	Time	Method
Number of Participants with all-cause mortality at 6 months.	6 months.	Main result variable.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ana Belén Fernández Laso; 🇪🇸 Vitoria-Gasteiz, Álava, Spain