Alcoholic HepatitisPhase 2AlcHepNetNCT04072822
Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
A Phase 2 study testing Anakinra and Zinc and Prednisone in people with Alcoholic Hepatitis, run by Indiana University at 10 sites in United States.
Trial summary
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- What is being tested?
- Anakinra and Zinc and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 10 sitesUnited States
- Study dates
- 10 Jul 2020to 12 Aug 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AH, as defined by the NIAAA pan-consortia for AH:
- Onset of jaundice (defined as serum total bilirubin >3 mg/dL) within the prior 8 weeks to screening visit
- Regular consumption of alcohol with an intake of > 40 gm daily or >280gm weekly on average for women and > 60 gm daily or >420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice
- AST > 50 IU/l
- AST:ALT > 1.5 and both values < 400 IU/l
- and/or histological evidence of AH*
Show all 9Show fewer
- MELD 20-35 on day of randomization.
- Ages >21
- In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST < 50 IU/L or > 400 IU/L, AST/ALT ratio < 1.5), antinuclear antibody > 1:160 or SMA > 1:80, a standard of care liver biopsy may be performed during current hospital admission to confirm AH and exclude competing etiologies
Who cannot join
- MELD SCORE <20 or > 35
- Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion
- Pneumonia as evidenced by radiological exam
- Multi-organ failure
- Renal failure defined by GFR <35 mL/min by CKD-EPI.
- Clinically active C. diff infection
Show all 24Show fewer
- History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice
- History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI). Previously treated hepatitis C that was cured (sustained virological response with negative RNA ≥24 weeks following treatment) is not an exclusion.
- History of HIV infection (positive HIV RNA or on treatment for HIV infection)
- History or presence of cancer (including hepatocellular carcinoma) other than non- melanoma skin cancer
- History of other significant medical problems such as autoimmune diseases, severe asthma, psoriasis, Inflammatory Bowel Disease (IBD), etc. that might require immunosuppressive treatments
- Pregnancy or breastfeeding
- Prior exposure to experimental therapies in last 3 months
- Prior exposure to systemic corticosteroid (glucocorticoid) or immunosuppressive therapy for more than 4 days within previous 30 days
- Need for inotropic pressor support to maintain perfusion to critical organs within prior 48 hours before randomization and initiation of experimental treatment
- Clinically significant pancreatitis- abdominal pain, elevated lipase (> 3 X ULN) and at least edema of pancreas with fat-stranding on CT scan
- Total WBC count > 30,000/mm3
- Known allergy or intolerance to therapeutic agents to be tested
- Inability to voluntarily obtain informed consent from participant or guardian
- Perceived inability to follow study procedures and comply with protocol
- Platelet count < 40,000 k/cumm.
- Positive PCR test for COVID -19 within 7 days prior to the baseline day 0 visit
- Active gastrointestinal bleeding defined as hematemesis or melena with a decrease in hemoglobin more than 2 g/dl in 24 hrs. Due to gastrointestinal bleeding, or with a decrease in mean arterial BP to < 65 mmHg.
- Positive test is exclusionary only during screening period. If a patient tests positive any time after baseline randomization, a positive PCR test for COVID-19 will be considered as a SAE.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 01003
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern Medical School
Dallas, Texas, 75390
Indiana Universtiy
Indianapolis, Indiana, 46202-2879
Mayo Clinic
Jacksonville, Florida, 32224
University of Louisville
Louisville, Kentucky, 40292
Mayo Clinic
Phoenix, Arizona, 85054
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Virginia Commonwealth University
Richmond, Virginia, 23284
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases.
The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
- Conditions
- Alcoholic Hepatitis
- Being tested
- Anakinra and Zinc, Prednisone, Placebos
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra and ZincDrug
Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
PrednisoneDrug
Prednisone is indicated for numerous conditions including inflammatory disease. Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
PlacebosDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Active comparator | Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90). Receives: Drug: Prednisone; Drug: Placebos |
| Anakinra and Zinc | Active comparator | Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30). Receives: Drug: Anakinra and Zinc; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 90 Days
The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Measured: 90 days
Secondary outcomes (15)
To Measure the Changes in Lille Score
Change in Lille score is represented as the percentage of participants who achieved a Lille score < 0.45 on day 7.
The Lille score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis Lille score = (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(prothrombin time, sec) Renal insufficiency = 1 (if creatinine >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L)) The Lille score was developed to provide early recognition of patients with severe alcoholic hepatitis not responding to corticosteroids. Lower scores indicate more improvement in response to corticosteroids. A Lille score > 0.45 predicts worse 6-month survival. A Lille score < 0.45 predicts better 6-month survival.
Measured: Day 7
Changes in MELD Score
The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Measured: 7, 30, and 90 days
Number of Participants With AKI (Acute Kidney Injury)
- Increase in creatinine of 50% above baseline over a period of 7 days
- Increase in creatinine of 0.3 mg/dl within a period of 48 hrs
- Onset of renal failure requiring dialysis
Measured: 7, 30, and 90 days
Development of Multi-organ Failure
Defined as failure ≥2 organs
Measured: 7, 30, and 90 days
Development of SIRS (Systemic Inflammatory Response Syndrome)
Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points
Measured: 7, 30, and 90 days
Number of Transfers to ICU
Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation
Measured: 7, 30, and 90 days
Changes in Liver Function
Changes in liver function were evaluated by changes in the Child Pugh Score at days 7, 30, and 90. The Child Pugh Score is a scoring system used to assess the severity of chronic liver disease. Scores range from 5 to 15, with higher scores indicating more severe disease. Points are assigned as follows:
Hepatic encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, mild = 2 points, moderate to severe = 3 points Total Bilirubin: under 2 mg/dl = 1 point, 2 to 3 mg/dl = 2 points, over 3 mg/dl = 3 points Albumin: greater than 3.5g/dl = 1 point, 2.8 to 3.5g/dl = 2 points, less than 2.8g/dl = 3 points International normalised ratio (INR): under 1.7 = 1 point, 1.7 to 2.3 = 2 points, above 2.3 = 3 points
Assigned points for each category are summed to calculate the Child Pugh Score.
Measured: 7, 30, and 90 days
Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
The SOFA score will be calculated at the following website https://www.mdcalc.com/sequential-organ-failure-assessment-sofa-score
Scores can be from 0 - >14 (favorable to less favorable)
Measured: 180 days
Number of Participants With Infections
Measured: 180 days
Number of Participants With Progression of Sepsis
- Life-threatening organ dysfunction caused by a dysregulated host response to infection
- An increase in SOFA score of 2 points of more
- Note: most participants with severe AH have 4 points based on bilirubin only
Measured: 180 days
Percentage of Participants With Renal Dysfunction
Defined by a creatinine > 2 mg/dl
Measured: 180 days
Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.
Measured: 180 days
Indicators of Gut Permeability
Measured: 180 days
Survival
Measured: 30 days and 180 days
Transplant Free Survival Rate
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 posted28 Aug 2019
- Study start10 Jul 2020
- Primary completion24 May 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Samer Gawrieh, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072822
- Sponsor's protocol ID
- AlcHepNet-02
- Acronym
- AlcHepNet
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2019
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gawrieh S, Dasarathy S, Tu W, Kamath PS, Chalasani NP, McClain CJ, Bataller R, Szabo G, Tang Q, Radaeva S, Barton B, Nagy LE, Shah VH, Sanyal AJ, Mitchell MC; AlcHepNet Investigators. Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis. J Hepatol. 2024 May;80(5):684-693. doi: 10.1016/j.jhep.2024.01.031. Epub 2024 Feb 10.
PubMed 38342441Dasarathy S, Tu W, Bellar A, Welch N, Kettler C, Tang Q, Liangpunsakul S, Gawrieh S, Radaeva S, Mitchell M; AlcHepNet. Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the AlcHep Network. Contemp Clin Trials. 2024 Mar;138:107437. doi: 10.1016/j.cct.2024.107437. Epub 2024 Jan 11.
PubMed 38215876
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blinded, Placebo-controlled Clinical Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis by the AlcHepNet Consortium
- ClinicalTrials.gov ID
- NCT04072822
- Acronym / sponsor ID
- AlcHepNet / AlcHepNet-02
- Conditions
- Alcoholic Hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases.
The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Active comparator | Drug: Prednisone, Drug: PlacebosStandard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90). |
| Anakinra and Zinc | Active comparator | Drug: Anakinra and Zinc, Drug: PlacebosStandard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- AH, as defined by the NIAAA pan-consortia for AH:
- MELD 20-35 on day of randomization.
- Ages >21
Key exclusion criteria (24 listed)
- MELD SCORE <20 or > 35
- Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion
- Pneumonia as evidenced by radiological exam
- Multi-organ failure
- Renal failure defined by GFR <35 mL/min by CKD-EPI.
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 |
|---|---|---|
| Anakinra and ZincAnakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease. | Drug | Anakinra and Zinc |
| PrednisonePrednisone is indicated for numerous conditions including inflammatory disease. Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease. | Drug | Prednisone |
| PlacebosMatching placebo | Drug | Anakinra and Zinc, Prednisone |
Primary outcome
Survival at 90 Days
Time frame: 90 days
The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
15 secondary outcomes
To Measure the Changes in Lille Score
Time frame: Day 7
Changes in MELD Score
Time frame: 7, 30, and 90 days
Number of Participants With AKI (Acute Kidney Injury)
Time frame: 7, 30, and 90 days
Development of Multi-organ Failure
Time frame: 7, 30, and 90 days
Development of SIRS (Systemic Inflammatory Response Syndrome)
Time frame: 7, 30, and 90 days
Number of Transfers to ICU
Time frame: 7, 30, and 90 days
Changes in Liver Function
Time frame: 7, 30, and 90 days
Number of Participants With Changes in Sequential Organ Failure Assessment (SOFA) Scores and Proportions Requiring Hemodynamic Support for MAP < 65 mm Hg and Lactate > 2 mmol/l, Renal Replacement Therapy or Mechanical Ventilation.
Time frame: 180 days
Number of Participants With Infections
Time frame: 180 days
Number of Participants With Progression of Sepsis
Time frame: 180 days
Percentage of Participants With Renal Dysfunction
Time frame: 180 days
Number of Participants Requiring Transfer to ICU for Care, Intubation for Airway Control, Need for Ventilator Support or RRT.
Time frame: 180 days
Indicators of Gut Permeability
Time frame: 180 days
Survival
Time frame: 30 days and 180 days
Transplant Free Survival Rate
Time frame: 90 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38342441Gawrieh S, Dasarathy S, Tu W, Kamath PS, Chalasani NP, McClain CJ, Bataller R, Szabo G, Tang Q, Radaeva S, Barton B, Nagy LE, Shah VH, Sanyal AJ, Mitchell MC; AlcHepNet Investigators. Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis. J Hepatol. 2024 May;80(5):684-693. doi: 10.1016/j.jhep.2024.01.031. Epub 2024 Feb 10.
- Derived from this study: PubMed 38215876Dasarathy S, Tu W, Bellar A, Welch N, Kettler C, Tang Q, Liangpunsakul S, Gawrieh S, Radaeva S, Mitchell M; AlcHepNet. Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the AlcHep Network. Contemp Clin Trials. 2024 Mar;138:107437. doi: 10.1016/j.cct.2024.107437. Epub 2024 Jan 11.
- AlcHepNet WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra and Zinc and Prednisone in people with Alcoholic Hepatitis, run by Indiana University at 10 sites in United States.
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 9 inclusion and 24 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival at 90 Days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04072822, which also lists 2 linked publications.
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 10 Feb 2025.