Alcoholic HepatitisPhase 3PROCORNACNCT06956482
PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis
A Phase 3 study testing N-Acetylcysteine (NAC) Treatment, Prednisolone and Prednisolone 10mg in people with Alcoholic Hepatitis, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- N-Acetylcysteine (NAC) Treatment, Prednisolone and Prednisolone 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 477 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2026to May 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille, Hôpital Huriez
Lille, 59037
Alexandre Louvet, PhD, +33320445597, alexandre.louvet@chu-lille.fr
About this study
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 outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score < 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders by a Lille score greater than 0.56. In them, there is a consensus for stopping prednisolone after a 7-day course of treatment (Lille score is calculated after 7 days) while patients with a Lille score <0.56 continue treatment for a total of 30 days.
Numerous trials have attempted to test the impact of other strategies in association with prednisolone, but none of them has shown an improvement in survival (primary endpoint) as compared to prednisolone alone. These strategies include for instance pentoxifylline, amoxicillin-clavulanic acid and enteral nutrition.
Read more
Because oxidative stress is a major driver of liver injury during alcohol-related liver disease, antioxidants, especially N-acetylcysteine, have been tested for many years to treat alcoholic hepatitis. N-acetylcysteine alone does not seem to bring a survival benefit over placebo while it may improve outcome when combined to prednisolone.
Historically in severe alcoholic hepatitis, treatment is only given for one month. However, a significant proportion of patients still disclose impaired hepatic function after treatment has been stopped (e.g. 50% of patients still have a MELD score ≥17 after 60 days in). It is thus tempting to hypothesize that a proportion of patients will recover slowly and may take benefit from a prolonged treatment. Such strategy has been proposed in some old studies with relatively limited sample size but never tested with a rigorous approach.
In the present study, for the first time in alcoholic hepatitis, we will take into account the recent recommendations of international experts by choosing an innovative primary endpoint that does not only include mortality and evaluate this endpoint at the preferred timepoint of 90 days.
After more than 30 years of negative trials in severe alcoholic hepatitis, the present study is aimed to evaluate two important new strategies to decrease both mortality and liver impairment.
- Conditions
- Alcoholic Hepatitis
- Being tested
- N-Acetylcysteine (NAC) Treatment, Prednisolone, Placebo of N-acetylcysteine, Placebo of Prednisolone 10mg, Prednisolone 10mg
- Keywords
- Alcoholic hepatitis, survival, prednisolone, N-acetylcysteine, liver insufficiency
- Medical subject headings
- Hepatitis, Alcoholic, Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC) TreatmentDrug
N-acetylcysteine for five days (day 1 to day 5) at a daily dose of 300mg/Kg
PrednisoloneDrug
prednisolone 40 mg/day for a total of 30 days
Placebo of N-acetylcysteineDrug
Placebo of N-acetylcysteine for five days (day 1 to day 5)
Placebo of Prednisolone 10mgDrug
Placebo of prednisolone 10mg for 30 additional days
Prednisolone 10mgDrug
prednisolone 10mg (tapering dose) for 30 additional days
| Study group | Role | What they receive |
|---|---|---|
| NAC/Prednisolone/Placebo | Experimental | 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 Receives: Drug: N-Acetylcysteine (NAC) Treatment; Drug: Prednisolone; Drug: Placebo of Prednisolone 10mg |
| Placebo/Prednisolone/Placebo | Active comparator | 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 Receives: Drug: Prednisolone; Drug: Placebo of N-acetylcysteine; Drug: Placebo of Prednisolone 10mg |
| Placebo/Prednisolone/Prednisolone | Experimental | 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 Receives: Drug: Prednisolone; Drug: Placebo of N-acetylcysteine; Drug: Prednisolone 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start22 May 2026
- Primary completionAug 2026 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 477 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956482
- Sponsor's protocol ID
- 2024_0476
- Other IDs
- PHRC-23-0354, 2025-522109-39-00, 2025
- Acronym
- PROCORNAC
- Status last verified
- May 2026
- First submitted
- 25 Apr 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT06956482
- Acronym / sponsor ID
- PROCORNAC / 2024_0476
- Conditions
- Alcoholic Hepatitis
- Keywords
- Alcoholic hepatitis, survival, prednisolone, N-acetylcysteine, liver insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 477 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 May 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 outcome despite being treated with corticosteroids. Response to treatment can be predicted by the Lille score, a simple tool that is calculated after 7 days of prednisolone course. The ideal binary cut-off of the Lille is 0.45, responders having a Lille score < 0.45 and non-responders having a Lille score ≥0.45. In terms of treatment management, approximately 30% of patients with severe alcoholic hepatitis do not take benefit from prednisolone and are classified as null responders by a Lille score greater than 0.56. In them, there is a consensus for stopping prednisolone after a 7-day course of treatment (Lille score is calculated after 7 days) while patients with a Lille score <0.56 continue treatment for a total of 30 days.
Numerous trials have attempted to test the impact of other strategies in association with prednisolone, but none of them has shown an improvement in survival (primary endpoint) as compared to prednisolone alone. These strategies include for instance pentoxifylline, amoxicillin-clavulanic acid and enteral nutrition.
Because oxidative stress is a major driver of liver injury during alcohol-related liver disease, antioxidants, especially N-acetylcysteine, have been tested for many years to treat alcoholic hepatitis. N-acetylcysteine alone does not seem to bring a survival benefit over placebo while it may improve outcome when combined to prednisolone.
Historically in severe alcoholic hepatitis, treatment is only given for one month. However, a significant proportion of patients still disclose impaired hepatic function after treatment has been stopped (e.g. 50% of patients still have a MELD score ≥17 after 60 days in). It is thus tempting to hypothesize that a proportion of patients will recover slowly and may take benefit from a prolonged treatment. Such strategy has been proposed in some old studies with relatively limited sample size but never tested with a rigorous approach.
In the present study, for the first time in alcoholic hepatitis, we will take into account the recent recommendations of international experts by choosing an innovative primary endpoint that does not only include mortality and evaluate this endpoint at the preferred timepoint of 90 days.
After more than 30 years of negative trials in severe alcoholic hepatitis, the present study is aimed to evaluate two important new strategies to decrease both mortality and liver impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NAC/Prednisolone/Placebo | Experimental | Drug: N-Acetylcysteine (NAC) Treatment, Drug: Prednisolone, Drug: Placebo of Prednisolone 10mgN-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 |
| Placebo/Prednisolone/Placebo | Active comparator | Drug: Prednisolone, Drug: Placebo of N-acetylcysteine, Drug: Placebo of Prednisolone 10mgPlacebo 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 |
| Placebo/Prednisolone/Prednisolone | Experimental | Drug: Prednisolone, Drug: Placebo of N-acetylcysteine, Drug: Prednisolone 10mgPlacebo 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetylcysteine (NAC) TreatmentN-acetylcysteine for five days (day 1 to day 5) at a daily dose of 300mg/Kg | Drug | NAC/Prednisolone/Placebo |
| Prednisoloneprednisolone 40 mg/day for a total of 30 days | Drug | NAC/Prednisolone/Placebo, Placebo/Prednisolone/Placebo, Placebo/Prednisolone/Prednisolone |
| Placebo of N-acetylcysteinePlacebo of N-acetylcysteine for five days (day 1 to day 5) | Drug | Placebo/Prednisolone/Placebo, Placebo/Prednisolone/Prednisolone |
| Placebo of Prednisolone 10mgPlacebo of prednisolone 10mg for 30 additional days | Drug | NAC/Prednisolone/Placebo, Placebo/Prednisolone/Placebo |
| Prednisolone 10mgprednisolone 10mg (tapering dose) for 30 additional days | Drug | Placebo/Prednisolone/Prednisolone |
Primary outcome
Rate of patients alive with compensated liver disease
Time frame: 90 days
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-Acetylcysteine (NAC) Treatment, Prednisolone and Prednisolone 10mg in people with Alcoholic Hepatitis, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Louvet, Prof. (+33 (0)3 20 44 53 03, alexandre.louvet@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients alive with compensated liver disease (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.