NCT05294744

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Bioaraba Health Research Institute · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-07
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2022-03-24
• Last updated: 2026-01-12

Locations

1 site across 1 country: Spain