Ana Belén Fernández Laso
Vitoria-Gasteiz, Álava, 01009, Spain
Location status: Recruiting
NCT Number: NCT05294744
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Vitoria-Gasteiz, Álava, 01009, Spain
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months.
Main result variable.
Time frame: 3 months
Security variable.
Contact information is provided by the study sponsor or research team.
Ana Belén Fernández, Clinic
CONTACT
Inés Pérez, Coordinator
CONTACT
Bioaraba Health Research Institute
Network
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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