Prolonged steroids with NAC for severe alcoholic hepatitis
Official title: PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis
Run by University Hospital, Lille · NCT06956482 · Data updated 2026-11-12
This study tests whether adding N-acetylcysteine to prednisolone (or their placebos) improves outcomes for adults with severe alcoholic hepatitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 477 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | May 22, 2026 |
| Main results expected | August 2026 |
| Study ends | May 2030 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT06956482 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with biopsy-confirmed severe alcoholic hepatitis (Maddrey’s DF ≥ 32) and MELD ≥ 17, who consume substantial alcohol but meet safety criteria.
✕Probably not a fit
Patients with advanced comorbidities, active infections, certain contraindications to NAC or steroids, or those not meeting Lille-score-based response criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 3 trial enrolls adults 18–75 with biopsy-proven severe alcoholic hepatitis (Maddrey’s DF ≥ 32 and MELD ≥ 17). Participants are randomly assigned to receive prednisolone, N-acetylcysteine (NAC), both, or their respective placebos to 28 days of treatment, with outcomes including short-term survival and response markers. The trial builds on the existing standard of care with prednisolone and investigates whether NAC can enhance benefit or reduce harm in nonresponders as defined by Lille scoring after one week. Key eligibility requires significant alcohol use, jaundice onset within 3 months, and informed consent, while exclusions include hepatocellular carcinoma, severe comorbidity, active infections, and MELD < 17. Lead site is CHU de Lille, with University Hospital Lille coordinating.
Why it matters
Potential benefit: If successful, patients with severe alcoholic hepatitis could have improved survival or higher response rates with a combination therapy approach.
How similar studies have gone: Prior evidence supports prednisolone for short-term survival in severe alcoholic hepatitis; adding NAC is exploratory and has mixed prior signals, making this a novel/untested combination in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-75 * Alcohol consumption of more than 40g/day (women) and 50g/day (men) * Recent onset of jaundice (\<3 months) * Biopsy proven alcoholic hepatitis (transjugular liver biopsy) * Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis * MELD score ≥ 17 * Patients covered with social insurance * Patients having provided written informed consent to participate Exclusion Criteria: * Hepatocellular carcinoma * Uncontrolled gastrointestinal bleeding * Previous severe allergy or hypersensitivity to N-acetylcysteine (anaphylactic shock, Quincke edema, severe urticaria) * Hypersensitivity to any component of the medication * MELD score \<17 * Type 1 hepatorenal syndrome before the initiation of treatment * Severe extrahepatic disease, with life expectancy \< 6 months * Any malignant tumor \< 2 years (except skin carcinomas) * Ongoing viral or parasitic infection * Untreated bacterial infection * Tuberculosis \< 5 years * Positive blood PCR in patients with positive antibodies against HCV * Patient carrying HBV or HIV * Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study
Where it's running
-
CHU de Lille, Hôpital Huriez
Lille, France Recruiting
Study contacts
- Study coordinator: Alexandre Louvet, Prof.
- Email: alexandre.louvet@chu-lille.fr
- Phone: +33 (0)3 20 44 53 03
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.