NCT05294744 Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
| NCT ID | NCT05294744 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bioaraba Health Research Institute |
| Condition | Alcoholic Hepatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 390 participants |
| Start Date | 2022-10-07 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 390 participants in total. It began in 2022-10-07 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ana Belén Fernández, Clinic
PRINCIPAL INVESTIGATOR
HUA
Frequently Asked Questions
Who can join the NCT05294744 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Alcoholic Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05294744 currently recruiting?
Yes, NCT05294744 is actively recruiting participants. Contact the research team at anabelen.fernandezlaso@osakidetza.eus for enrollment information.
Where is the NCT05294744 trial being conducted?
This trial is being conducted at Vitoria-Gasteiz, Spain.
Who is sponsoring the NCT05294744 clinical trial?
NCT05294744 is sponsored by Bioaraba Health Research Institute. The principal investigator is Ana Belén Fernández, Clinic at HUA. The trial plans to enroll 390 participants.