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PROlonged Corticosteroid treatment or N-ACetylcysteine for severe alcoholic hepatitis (PROCORNAC)
EU CTIS ID: 2025-522109-39-00
What this study is testing
To assess the efficacy of the combination of N-acetylcysteine during 5 days with standard treatment by prednisolone (prednisolone during 30 days) or a prolonged treatment with prednisolone (during a total of 60 days) compared to standard treatment with prednisolone during 30 days to improve the rate of alive patients with compensated liver disease at 90 days.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Hepatocellular carcinoma
- Untreated bacterial infection. Patients on antibiotics to treat ongoing infection can be included if the investigator feels the sepsis is under control.
- 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
See the full eligibility 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
- Hepatocellular carcinoma
- Untreated bacterial infection. Patients on antibiotics to treat ongoing infection can be included if the investigator feels the sepsis is under control.
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.