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New treatment option for Alcoholic Hepatitis
Official title PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis
ClinicalTrials.gov ID: NCT06956482
What this study is testing
What is N-Acetylcysteine (NAC) Treatment?
N-Acetylcysteine (NAC) Treatment is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcoholic hepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
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
You likely can't join if
- 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
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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.