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Clinical Trial NCT06956482 (PROCORNAC) for Alcoholic Hepatitis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis (PROCORNAC) Phase 3 477 International Short-Term

Not yet recruiting
Clinical Trial NCT06956482 (PROCORNAC) is designed to study Treatment for Alcoholic Hepatitis. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 February 2026 until the study accrues 477 participants. Led by University Hospital, Lille, this study is expected to complete by 1 January 2027. The latest data from ClinicalTrials.gov was last updated on 20 January 2026.
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 has been proven to improve short-term survival over placebo in patients with severe alcoholic hepatitis. However, prednisolone alone cannot be regarded as an ideal treatment because some patients still have a bad outcom...Show More
Official Title

PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

Conditions
Alcoholic Hepatitis
Other Study IDs
  • PROCORNAC
  • 2024_0476
  • PHRC-23-0354 (Other Grant/Funding Number) (DGOS, France)
  • 2025-522109-39-00 (EU Study (CTIS) Number)
NCT ID Number
NCT06956482
Start Date (Actual)
2026-02
Last Update Posted
2026-01-20
Completion Date (Estimated)
2027-01
Enrollment (Estimated)
477
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Alcoholic hepatitis
survival, prednisolone
N-acetylcysteine
liver insufficiency
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalNAC/Prednisolone/Placebo
N-acetylcysteine for five days (day 1 to day 5) in combination with prednisolone 40 mg/day for a total of 30 days, followed by a placebo for 30 additional days
N-Acetylcysteine (NAC) Treatment
N-acetylcysteine for five days (day 1 to day 5) at a daily dose of 300mg/Kg
Prednisolone
prednisolone 40 mg/day for a total of 30 days
Placebo of Prednisolone 10mg
Placebo of prednisolone 10mg for 30 additional days
Active ComparatorPlacebo/Prednisolone/Placebo
Placebo for five days (day 1 to day 5) in combination with prednisolone 40 mg/day for a total of 30 days, followed by a placebo for 30 additional days
Prednisolone
prednisolone 40 mg/day for a total of 30 days
Placebo of N-acetylcysteine
Placebo of N-acetylcysteine for five days (day 1 to day 5)
Placebo of Prednisolone 10mg
Placebo of prednisolone 10mg for 30 additional days
ExperimentalPlacebo/Prednisolone/Prednisolone
Placebo for five days (day 1 to day 5) in combination with prednisolone 40 mg/day for a total of 30 days, followed by prednisolone (tapering dose) for 30 additional days
Prednisolone
prednisolone 40 mg/day for a total of 30 days
Placebo of N-acetylcysteine
Placebo of N-acetylcysteine for five days (day 1 to day 5)
Prednisolone 10mg
prednisolone 10mg (tapering dose) for 30 additional days
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rate of patients alive with compensated liver disease
Rate of patients alive with compensated liver disease defined as a MELD score \<17 at 90 days. MELD score will be calculated according to the formula given in Dunn et al. Hepatology 2005: MELD = 9.57 x ln (creatinine in mg/dL) + 3.78 x ln (bilirubin in mg/dL) + 11.2 x ln (INR) + 6.43
90 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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
  • 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
University Hospital, Lille logoUniversity Hospital, Lille
Study Central Contact
Contact: Alexandre Louvet, Prof., +33 (0)3 20 44 53 03, [email protected]
No location data.