Alcoholic HepatitisNCT05294744
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
A study testing N-acetylcysteine in people with Alcoholic Hepatitis, run by Bioaraba Health Research Institute at 1 site in Spain.
Trial summary
This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids. 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSpain
- Study dates
- 7 Oct 2022to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women.
- Age from 18 to 75 years.
- Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
- Maddrey score> = 32.
- Acceptance of participation through written informed consent.
Who cannot join
- Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
- Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
- Hepatocarcinoma.
- Portal cavernomatosis.
- Portal cavernomatosis.
- Any disease whose life expectancy is less than 12 months.
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- Patients with nitroglycerin and / or carbamazepine-based treatments.
- Patients with uncontrolled active infection.
- Acute kidney disease with creatinine> 2.5 mg / dL.
- Uncontrolled upper gastrointestinal bleeding.
- Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).
- Multiple organ failure or shock.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.
Read the detailed description
Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects.
Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.
Clinical, randomized, controlled, multicenter, parallel and open trial.
- Conditions
- Alcoholic Hepatitis
- Being tested
- N-acetylcysteine
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Day 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously.
Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids | Active comparator | Corticosteroids following Standard Clinical Practice Receives: Drug: N-acetylcysteine |
| Corticosteroids + N-acetylcysteine | Experimental | Corticosteroids following Standard Clinical Practice plus N-acetylcisteine Receives: Drug: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with all-cause mortality at 6 months.
Main result variable.
Measured: 6 months.
Secondary outcomes (1)
Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.
Security variable.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start7 Oct 2022
- Primary completion31 Jul 2026
- Study completion1 Oct 2026
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, randomized, controlled, multicenter, parallel and open trial.
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaraba Health Research Institute
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ana Belén Fernández Laso, Bioaraba Health Research Institute
- Investigators
- Ana Belén Fernández, Clinic, Principal investigator, HUA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294744
- Sponsor's protocol ID
- CONACHAA
- Other IDs
- 2020-004549-35
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
- ClinicalTrials.gov ID
- NCT05294744
- Acronym / sponsor ID
- CONACHAA
- Conditions
- Alcoholic Hepatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Bioaraba Health Research InstituteResearch network
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 24 Mar 2022 (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.
This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.
Detailed description
Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects.
Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.
Clinical, randomized, controlled, multicenter, parallel and open trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical, randomized, controlled, multicenter, parallel and open trial.
| Arm | Type | Receives |
|---|---|---|
| Corticosteroids | Active comparator | Drug: N-acetylcysteineCorticosteroids following Standard Clinical Practice |
| Corticosteroids + N-acetylcysteine | Experimental | Drug: N-acetylcysteineCorticosteroids following Standard Clinical Practice plus N-acetylcisteine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women.
- Age from 18 to 75 years.
- Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
- Maddrey score> = 32.
- Acceptance of participation through written informed consent.
Key exclusion criteria (12 listed)
- Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
- Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
- Hepatocarcinoma.
- Portal cavernomatosis.
- Portal cavernomatosis.
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-acetylcysteineDay 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously. Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h. | Drug | Corticosteroids, Corticosteroids + N-acetylcysteine |
Primary outcome
Number of Participants with all-cause mortality at 6 months.
Time frame: 6 months.
Main result variable.
1 secondary outcome
Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. There is no a plan to make individual participant data (IPD) available to other researchers.
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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. This study is not recruiting at the moment.
Ana Belén Fernández, Clinic principal investigator
HUA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine in people with Alcoholic Hepatitis, run by Bioaraba Health Research Institute at 1 site in Spain.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 16 Oct 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with all-cause mortality at 6 months. (time frame: 6 months.). 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 16 Oct 2026.