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

Bioaraba Health Research Institute

Status: Unknown

Conditions: Alcoholic Hepatitis

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05294744

2020-004549-35 (EudraCT Number)

CONACHAA

Details and patient eligibility

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.

Full 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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

390 participants in 2 patient groups

Corticosteroids

Active Comparator group

Description:

Corticosteroids following Standard Clinical Practice

Treatment:

Drug: N-acetylcysteine

Corticosteroids + N-acetylcysteine

Experimental group

Description:

Corticosteroids following Standard Clinical Practice plus N-acetylcisteine

Treatment:

Drug: N-acetylcysteine