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

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05294744
• Other study ID #: CONACHAA
• Secondary ID: 2020-004549-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: July 2023

Study information

• Verified date: March 2022
• Source: Bioaraba Health Research Institute
• Contact: Ana Belén Fernández, Clinic
• Phone: 945007000
• Email: anabelen.fernandezlaso[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 390
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

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.

Locations

Country	Name	City	State
Spain	Ana Belén Fernández Laso	Vitoria-Gasteiz	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Bioaraba Health Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with all-cause mortality at 6 months.	Main result variable.	6 months.
Secondary	Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.	Security variable.	3 months