Status:
NOT_YET_RECRUITING
PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis
Lead Sponsor:
University Hospital, Lille
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Only patients suffering from a severe form of alcoholic hepatitis (Maddrey's discriminant function greater than 32) require medical treatment. Oral prednisolone for 28 days is the only treatment which...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT06956482
Start Date
October 1 2025
End Date
October 1 2026
Last Update
May 4 2025
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