Clinical trial NCT05294744: Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Official title: Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcoholic Hepatitis
Lead sponsor: Bioaraba Health Research Institute
Sponsor class: NETWORK
First posted: 2022-03-24
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical, randomized, controlled, multicenter, parallel and open trial.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants with all-cause mortality at 6 months.
timeFrame: 6 months.
Secondary outcomes:
measure: Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.
timeFrame: 3 months
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Ana Belén Fernández Laso
state: Álava
Study officials:
affiliation: HUA
name: Ana Belén Fernández, Clinic
role: PRINCIPAL_INVESTIGATOR
References: