Adding N-acetylcysteine to steroid treatment for severe alcoholic hepatitis (Maddrey >32)
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
This trial will try whether adding N-acetylcysteine to standard steroid treatment helps adults aged 18–75 with severe alcoholic hepatitis (Maddrey ≥32) have fewer complications and a lower risk of death than steroids alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bioaraba Health Research Institute Research network |
| Locations | 1 site (Vitoria-Gasteiz, Álava) |
| Trial ID | NCT05294744 on ClinicalTrials.gov |
What this trial studies
Adults with severe acute alcoholic hepatitis (Maddrey score ≥32) are randomized in an open-label, multicenter, parallel-design trial to receive standard corticosteroid therapy with or without adjunctive N-acetylcysteine (NAC). The trial compares morbidity and mortality between the two groups and records safety and adverse events related to both treatments. Eligible patients meet AASLD criteria or have compatible liver histology and are aged 18–75 years. The randomized, controlled, pragmatic design aims to provide clearer evidence on whether NAC adds benefit to current steroid-based care.
Who should consider this trial
Good fit: Adults aged 18–75 with severe acute alcoholic hepatitis (Maddrey ≥32) meeting AASLD criteria or compatible liver histology who can provide informed consent.
Not a fit: Patients with allergy to NAC or corticosteroids, uncontrolled active infection, significant renal failure (creatinine >2.5 mg/dL), hepatocellular carcinoma, portal cavernomatosis, other life-limiting illnesses, or those on contraindicated medications are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, adding NAC to steroids could reduce complications and short-term deaths in patients with severe alcoholic hepatitis.
How similar studies have performed: Previous smaller studies of NAC in alcoholic hepatitis have reported mixed results, so the benefit remains unproven and larger trials are recommended.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vitoria-Gasteiz, Álava
- Ana Belén Fernández Laso — Vitoria-Gasteiz, Álava, Spain (Recruiting)
Study contacts
- Principal investigator: Ana Belén Fernández, Clinic — Hua
- Study coordinator: Ana Belén Fernández, Clinic
- Email: anabelen.fernandezlaso@osakidetza.eus
- Phone: 945007000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.