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

Sponsor

Bioaraba Health Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05294744

Collaborator

(none)

390

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Hepatitis	Drug: N-acetylcysteine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical, randomized, controlled, multicenter, parallel and open trial.Clinical, randomized, controlled, multicenter, parallel and open trial.

Masking:

None (Open Label)

Masking Description:

This is an open trial.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Corticosteroids Corticosteroids following Standard Clinical Practice	Drug: N-acetylcysteine Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously. Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.
Experimental: Corticosteroids + N-acetylcysteine Corticosteroids following Standard Clinical Practice plus N-acetylcisteine	Drug: N-acetylcysteine Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously. Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.

Arm

Intervention/Treatment

Active Comparator: Corticosteroids

Corticosteroids following Standard Clinical Practice

Drug: N-acetylcysteine

Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously. Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.

Experimental: Corticosteroids + N-acetylcysteine

Corticosteroids following Standard Clinical Practice plus N-acetylcisteine

Drug: N-acetylcysteine

Outcome Measures

Primary Outcome Measures

Number of Participants with all-cause mortality at 6 months. [6 months.]
Main result variable.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ana Belén Fernández Laso	Vitoria-Gasteiz	Álava	Spain	01009

Sponsors and Collaborators

Bioaraba Health Research Institute

Investigators

Principal Investigator: Ana Belén Fernández, Clinic, HUA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ana Belén Fernández Laso, Principal Investigator, Bioaraba Health Research Institute

ClinicalTrials.gov Identifier:

NCT05294744

Other Study ID Numbers:

CONACHAA
2020-004549-35

First Posted:

Mar 24, 2022

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022