Trial · NCT01809132

Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis

NCT01809132, Phase 2, Phase 3, Completed, Mack Mitchell; results first posted 2020-12-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis. Trials, record NCT01809132. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01809132

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Trial

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

Title: Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
NCT number: NCT01809132
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 104 participants, actual
Lead sponsor: Mack Mitchell
Conditions: Acute Alcoholic Hepatitis
Interventions: Anakinra, Pentoxifylline, Zinc Sulfate, Methylprednisolone
First posted: 2013-03-12
Last updated: 2021-11-01
Results first posted: 2020-12-10

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	180 Days Mortality	Time to event up to 6 months	Death at 180 days
Secondary	MELD Score at 28 Days	28 days	Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.
Secondary	MELD Score at 90 Days	90 Days	Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.
Secondary	MELD Score at 180 Days	180 Days	Model of End Stage Liver Disease Score calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR). MELD score ranges from 6-40. A higher score indicates a lesser outcome. The Model for End Stage Liver Disease scoring system is based on the INR, total serum bilirubin and serum creatinine. The measure reflects 90 day prognosis of alcohol associated liver disease from the time of measurement and therefore can only be assessed on subjects who are alive at the specified time point since lab values from that time point are required for the measure.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	180 Days Mortality	Time to event up to 6 months	Intention to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	MELD Score at 28 Days	28 days	This outcome could not be calculated for the observational subject who was lost to follow up.~Analysis were limited to the subjects that were alive for this time point.	score on a scale	MEAN
SECONDARY	MELD Score at 90 Days	90 Days	This outcome could not be calculated for the observational subject who was lost to follow up.~Analysis were limited to the subjects that were alive for this time point.	score on a scale	MEAN
SECONDARY	MELD Score at 180 Days	180 Days	This outcome could not be calculated for the observational subject who was lost to follow up.~Analysis were limited to the subjects that were alive for this time point.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Spread	Units
180 Days Mortality	Anakinra & Pentoxifylline & Zinc Sulfate	17		Participants
180 Days Mortality	Methylprednisolone	22		Participants
180 Days Mortality	Observational	0		Participants
MELD Score at 28 Days	Anakinra & Pentoxifylline & Zinc Sulfate	22.57	Standard Deviation 6.31	score on a scale
MELD Score at 28 Days	Methylprednisolone	20.95	Standard Deviation 6.44	score on a scale
MELD Score at 90 Days	Anakinra & Pentoxifylline & Zinc Sulfate	15.50	Standard Deviation 6.11	score on a scale
MELD Score at 90 Days	Methylprednisolone	16.38	Standard Deviation 9.58	score on a scale
MELD Score at 180 Days	Anakinra & Pentoxifylline & Zinc Sulfate	15.81	Standard Deviation 10.10	score on a scale
MELD Score at 180 Days	Methylprednisolone	11.85	Standard Deviation 4.47	score on a scale

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Anakinra & Pentoxifylline & Zinc Sulfate	53
Overall Study	STARTED	Methylprednisolone	50
Overall Study	STARTED	Observational	1
Overall Study	COMPLETED	Anakinra & Pentoxifylline & Zinc Sulfate	53
Overall Study	COMPLETED	Methylprednisolone	50
Overall Study	COMPLETED	Observational	0
Overall Study	NOT COMPLETED	Anakinra & Pentoxifylline & Zinc Sulfate	0
Overall Study	NOT COMPLETED	Methylprednisolone	0
Overall Study	NOT COMPLETED	Observational	1

Source ClinicalTrials.gov

Adverse events81

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	Nausea	Gastrointestinal disorders	Anakinra & Pentoxifylline & Zinc Sulfate	5	53	5
other	Nausea	Gastrointestinal disorders	Methylprednisolone	0	50	0
other	Nausea	Gastrointestinal disorders	Observational	0	0	0
other	Urinary tract infection	Renal and urinary disorders	Anakinra & Pentoxifylline & Zinc Sulfate	5	53	5
other	Urinary tract infection	Renal and urinary disorders	Methylprednisolone	0	50	0
other	Urinary tract infection	Renal and urinary disorders	Observational	0	0	0
other	Hematemesis	Vascular disorders	Anakinra & Pentoxifylline & Zinc Sulfate	4	53	4
other	Hematemesis	Vascular disorders	Methylprednisolone	0	50	0
other	Hematemesis	Vascular disorders	Observational	0	0	0
other	Ascites	Hepatobiliary disorders	Anakinra & Pentoxifylline & Zinc Sulfate	3	53	3

1 to 10 of 81Source ClinicalTrials.gov

See all 81 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Anakinra & Pentoxifylline & Zinc Sulfate	17	53
Total, all-cause mortality	Methylprednisolone	22	50
Total, all-cause mortality	Observational	0	0
Total, other adverse events	Anakinra & Pentoxifylline & Zinc Sulfate	20	53
Total, other adverse events	Methylprednisolone	4	50
Total, other adverse events	Observational	0	0
Total, serious adverse events	Anakinra & Pentoxifylline & Zinc Sulfate	33	53
Total, serious adverse events	Methylprednisolone	30	50
Total, serious adverse events	Observational	0	0

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31811953	DERIVED	PubMed
35084335	DERIVED	PubMed
35340032	DERIVED	PubMed
37011138	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AA021893	Novel Therapies for Alcoholic Hepatitis	MCCULLOUGH, ARTHUR JOSEPH; MCCLAIN, CRAIG J.; MITCHELL, MACK CLARENCE; SZABO, GYONGYI	CLEVELAND CLINIC LERNER COM-CWRU	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2012 to 2017

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT01809132

GET https://conductscience.org/api/trials/v1/NCT01809132/events?page=2

API reference For AI assistants