Trial · NCT04072822

Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis

NCT04072822, Phase 2, Completed, Indiana University; results first posted 2023-07-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis. Trials, record NCT04072822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04072822

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
NCT number: NCT04072822
Status: Completed
Phases: Phase 2
Enrollment: 147 participants, actual
Lead sponsor: Indiana University
Conditions: Alcoholic Hepatitis
Interventions: Anakinra and Zinc, Prednisone, Placebos
First posted: 2019-08-28
Last updated: 2025-02-10
Results first posted: 2023-07-28

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Survival at 90 Days	90 days	The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Secondary	To Measure the Changes in Lille Score	Day 7	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.
Secondary	Changes in MELD Score	7, 30, and 90 days	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.
Secondary	Number of Participants With AKI (Acute Kidney Injury)	7, 30, and 90 days	* 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
Secondary	Development of Multi-organ Failure	7, 30, and 90 days	Defined as failure ≥2 organs
Secondary	Development of SIRS (Systemic Inflammatory Response Syndrome)	7, 30, and 90 days	Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points
Secondary	Number of Transfers to ICU	7, 30, and 90 days	Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation
Secondary	Changes in Liver Function	7, 30, and 90 days	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.
Secondary	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.	180 days	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)
Secondary	Number of Participants With Infections	180 days

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Survival at 90 Days	90 days		percentage of participants	NUMBER
SECONDARY	To Measure the Changes in Lille Score	Day 7	Participant numbers may vary from participant workflow module due to the data that was able to be collected at sites and timepoints.	percentage of participants	NUMBER
SECONDARY	Changes in MELD Score	7, 30, and 90 days	Participant numbers may vary from participant workflow module due to the data that was able to be collected at sites and timepoints.	scores on a scale	MEAN
SECONDARY	Number of Participants With AKI (Acute Kidney Injury)	7, 30, and 90 days		Participants	NUMBER
SECONDARY	Development of Multi-organ Failure	7, 30, and 90 days		Number of Subjects	NUMBER
SECONDARY	Development of SIRS (Systemic Inflammatory Response Syndrome)	7, 30, and 90 days		Events	NUMBER
SECONDARY	Number of Transfers to ICU	7, 30, and 90 days		Transfers	NUMBER
SECONDARY	Changes in Liver Function	7, 30, and 90 days	Due to lab issues and participant follow-up at certain sites, numbers analyzed differ from lab test to timepoint	score on a scale	MEAN
SECONDARY	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.	180 days		Participants	NUMBER
SECONDARY	Number of Participants With Infections	180 days		participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Survival at 90 Days	Prednisone		90		percentage of participants
Survival at 90 Days	Anakinra and Zinc		70		percentage of participants
To Measure the Changes in Lille Score	Prednisone		67.8		percentage of participants
To Measure the Changes in Lille Score	Anakinra and Zinc		65.6		percentage of participants
Changes in MELD Score	Prednisone	Day 7	-2.8	Standard Deviation 2.9	scores on a scale
Changes in MELD Score	Anakinra and Zinc	Day 7	0.2	Standard Deviation 4.6	scores on a scale
Changes in MELD Score	Prednisone	Day 30	-6.9	Standard Deviation 5.3	scores on a scale
Changes in MELD Score	Anakinra and Zinc	Day 30	-1.6	Standard Deviation 8.3	scores on a scale
Changes in MELD Score	Prednisone	Day 90	-10.3	Standard Deviation 6.1	scores on a scale
Changes in MELD Score	Anakinra and Zinc	Day 90	-8.1	Standard Deviation 7.1	scores on a scale

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment	STARTED	Prednisone	73
Treatment	STARTED	Anakinra and Zinc	74
Treatment	COMPLETED	Prednisone	30
Treatment	COMPLETED	Anakinra and Zinc	20
Treatment	NOT COMPLETED	Prednisone	43
Treatment	NOT COMPLETED	Anakinra and Zinc	54
Follow-up	STARTED	Prednisone	30
Follow-up	STARTED	Anakinra and Zinc	20
Follow-up	COMPLETED	Prednisone	24
Follow-up	COMPLETED	Anakinra and Zinc	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events522

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal Distension	Gastrointestinal disorders	Prednisone	0	73	0
other	Abdominal Distension	Gastrointestinal disorders	Anakinra and Zinc	1	74	2
other	Abdominal pain	Gastrointestinal disorders	Prednisone	2	73	2
other	Abdominal pain	Gastrointestinal disorders	Anakinra and Zinc	4	74	4
other	Abnormal chest sounds	Respiratory, thoracic and mediastinal disorders	Prednisone	0	73	0
other	Abnormal chest sounds	Respiratory, thoracic and mediastinal disorders	Anakinra and Zinc	2	74	2
other	Abnormal uterine bleeding	Reproductive system and breast disorders	Prednisone	0	73	0
other	Abnormal uterine bleeding	Reproductive system and breast disorders	Anakinra and Zinc	1	74	1
other	Accidental overdose (therapeutic agent)	Injury, poisoning and procedural complications	Prednisone	1	73	1
other	Accidental overdose (therapeutic agent)	Injury, poisoning and procedural complications	Anakinra and Zinc	0	74	0

1 to 10 of 522Source ClinicalTrials.gov

See all 522 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prednisone	12	73
Total, all-cause mortality	Anakinra and Zinc	22	74
Total, other adverse events	Prednisone	45	73
Total, other adverse events	Anakinra and Zinc	51	74
Total, serious adverse events	Prednisone	41	73
Total, serious adverse events	Anakinra and Zinc	49	74

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38215876	DERIVED	PubMed
38342441	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Prednisone vs Anakinra and Zinc: deaths from any cause	Trial comparisons
Prednisone vs Anakinra and Zinc: Number of Participants With Infections	Trial comparisons
Prednisone vs Anakinra and Zinc: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04072822

GET https://conductscience.org/api/trials/v1/NCT04072822/results?page=2

API reference For AI assistants