Alcoholic HepatitisPhase 2AHFIRMNCT04563026

A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

A Phase 2 study testing DUR-928 30 mg and DUR-928 90 mg in people with Alcoholic Hepatitis, run by Durect at 68 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcoholic Hepatitis
What is being tested?: DUR-928 30 mg and DUR-928 90 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 307 participants
Where: 68 sitesin 6 countries
Study dates: 22 Jan 2021to 6 Sep 2023
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to provide written informed consent (either from subject or subject's legally acceptable representative).
Onset of jaundice within prior 8 weeks.
Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice.
The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:
Serum total bilirubin > 3.0 mg/dL
50 < AST < 400 IU/L

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ALT < 400 IU/L
AST/ALT > 1.5
Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
Model for End-stage Liver Disease (MELD) score: 21-30.
Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have occurred during the current episode.
Male or female subjects 18 years of age or older.
Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.

Who cannot join

Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
Serum creatinine >2.5 mg/dL.
Subjects undergoing continuous veno-venous hemodialysis (CVVH).
Uncontrolled gastrointestinal bleeding.

Show all 17Show fewer

A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
Liver biopsy (if carried out) with findings not compatible with AH.
Stage ≥3 hepatic encephalopathy by West Haven criteria.
Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
Other concomitant cause(s) of liver disease.
Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
Existing or intended pregnancy or breast feeding.
Participation in another interventional clinical trial within 30 days of Screening.
History of organ transplantation, other than a corneal transplant.
Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.

Trial locations and contacts

68 sites in 6 countries.

Country

City, postcode or hospital

68 sites in 6 countries

United States48 sites

University of New Mexico (UNM) Hospital
Albuquerque, New Mexico, 87106
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21205
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina (MUSC) Health - University Medical Center
Charleston, South Carolina, 29425
Atrium Health
Charlotte, North Carolina, 28204
University of Virginia (UVA) Health - University Hospital
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Southern California Research Center
Coronado, California, 92118
Methodist Dallas Medical Center
Dallas, Texas, 75203
Parkland Memorial Hospital
Dallas, Texas, 75235
Baylor Scott and White Health
Dallas, Texas, 75246
University of Texas Southwestern (Clements University Hospital)
Dallas, Texas, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Doctors Hospital at Renaissance (DHR)
Edinburg, Texas, 78539
Baylor College of Medicine Medical Center
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Richard Roudebush VA Hospital
Indianapolis, Indiana, 46202
Saint Luke's Health System - Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Keck Hospital of University of Southern California (USC)
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
Northwell Health - North Shore University Hospital
Manhasset, New York, 11030
Loyola University Medical Center
Maywood, Illinois, 60153
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Yale University School of Medicine
New Haven, Connecticut, 06510
Tulane Medical Center
New Orleans, Louisiana, 70112
Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian - Weill Cornell Medical Center
New York, New York, 10065
Rutgers-New Jersey Medical School
Newark, New Jersey, 07103
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, 68198
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
University of California Davis (UC Davis) Medical Center
Sacramento, California, 95817
Utah Health - The University of Utah Hospital
Salt Lake City, Utah, 84132
University of California San Francisco (UCSF) Medical Center
San Francisco, California, 94143
Harborview Medical Center - University of Washington
Seattle, Washington, 98104
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
MedStar Health - MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

Australia8 sites

Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Eastern Health - Box Hill Hospital
Box Hill, Victoria, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Nepean Hospital
Kingswood, New South Wales, 2217
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Perth Hospital
Perth, Western Australia, 6000
Mater Health - Mater Hospital Brisbane
South Brisbane, Queensland, 4101

Other trials in Australia

United Kingdom5 sites

Barts Health NHS Trust - The Royal London Hospital
London, England, E1 1FR
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS
Imperial College Healthcare NHS Trust - St. Mary's Hospital
London, England, W2 1NY
Royal Free London NHS Foundation Trust Hospital
London, NW3 2QG
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, England, PL6 8DH

Other trials in United Kingdom

France4 sites

Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz
Besançon, 25000
Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre
Lille, 59037
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, 69004
Hôpital St Joseph
Marseille, 13008

Other trials in France

Belgium2 sites

Université libre de Bruxelles (ULB) - Hôpital Erasme
Brussels, 1070
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, 2650

Other trials in Belgium

Austria1 site

Landeskrankenhaus (LKH) - Universitätsklinikum Graz
Graz, 8036

Other trials in Austria

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis

This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

Conditions: Alcoholic Hepatitis
Being tested: DUR-928 30 mg, DUR-928 90 mg, Placebo+ Standard of Care (SOC)
Keywords: Alcoholic Hepatitis, acute alcoholic liver disease, progressive inflammatory liver injury
Medical subject headings: Hepatitis, Alcoholic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DUR-928 30 mgDrug
IV infusion
DUR-928 90 mgDrug
IV infusion
Placebo+ Standard of Care (SOC)Drug
IV infusion

Study groups in NCT04563026
Study group	Role	What they receive
DUR-928 (larsucosterol, 30 mg)	Experimental	Not described Receives: Drug: DUR-928 30 mg
DUR-928 (larsucosterol, 90 mg)	Experimental	Not described Receives: Drug: DUR-928 90 mg
(Placebo) Sterile Water for Injection	Placebo comparator	Not described Receives: Drug: Placebo+ Standard of Care (SOC)

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Measured: Day 90

Secondary outcomes (3)

Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Measured: Day 90
Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Measured: Day 28
Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 20216 Sep 2023

First posted24 Sep 2020
Study start22 Jan 2021
Primary completion6 Sep 2023
Study completion6 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a Phase 2b randomized, double-blind, placebo-controlled, multi-arm, multi-center, parallel design trial.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04563026
Sponsor's protocol ID: C928-011
Acronym: AHFIRM
Status last verified: Sep 2024
First submitted: 18 Sep 2020
Last updated: 5 Sep 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Liangpunsakul S, Krebs WB, Kwong AJ, Kwo PY, Brown RS Jr, Lin W, Sussman NL. The impact of liver transplantation on endpoint selection in alcohol-associated hepatitis trials. Hepatol Commun. 2025 Apr 30;9(5):e0709. doi: 10.1097/HC9.0000000000000709. eCollection 2025 May 1.
PubMed 40304564
Shiffman M, Da B, Goel A, Kwong A, Stein L, Moreno C, Nicoll A, Mehta A, Louvet A, Flamm S, Pyrsopoulos N, Satapathy S, Kuo A, Ganger D, Aloman C, Strasser SI, Tse E, Russo MW, Rockey D, Gray M, Mitchell M, Thursz M, Krebs W, Scott D, Blevins C, Ellis D, Brown J, Sussman N, Lin W. Larsucosterol for the Treatment of Alcohol-Associated Hepatitis. NEJM Evid. 2025 Feb;4(2):EVIDoa2400243. doi: 10.1056/EVIDoa2400243. Epub 2025 Jan 28.
PubMed 39873544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Hepatitis
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
RecruitingPhase 2
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Cirrhosis, Cirrhosis, Liver

All Alcoholic Hepatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
ClinicalTrials.gov ID: NCT04563026
Acronym / sponsor ID: AHFIRM / C928-011
Conditions: Alcoholic Hepatitis
Keywords: Alcoholic Hepatitis, acute alcoholic liver disease, progressive inflammatory liver injury
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: DurectIndustry (pharma, biotech, devices)
Collaborators: CTI Clinical Trial and Consulting Services
Study start: 22 Jan 2021 (actual)
Primary completion: 6 Sep 2023 (actual)
Study completion: 6 Sep 2023 (actual)
First posted: 24 Sep 2020 (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 is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: This is a Phase 2b randomized, double-blind, placebo-controlled, multi-arm, multi-center, parallel design trial.

Arm	Type	Receives
DUR-928 (larsucosterol, 30 mg)	Experimental	Drug: DUR-928 30 mg
DUR-928 (larsucosterol, 90 mg)	Experimental	Drug: DUR-928 90 mg
(Placebo) Sterile Water for Injection	Placebo comparator	Drug: Placebo+ Standard of Care (SOC)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Able to provide written informed consent (either from subject or subject's legally acceptable representative).
Onset of jaundice within prior 8 weeks.
Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice.
The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:
Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.

Key exclusion criteria (17 listed)

Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
Serum creatinine >2.5 mg/dL.
Subjects undergoing continuous veno-venous hemodialysis (CVVH).

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
DUR-928 30 mgIV infusion	Drug	DUR-928 (larsucosterol, 30 mg)
DUR-928 90 mgIV infusion	Drug	DUR-928 (larsucosterol, 90 mg)
Placebo+ Standard of Care (SOC)IV infusion	Drug	(Placebo) Sterile Water for Injection

Primary outcome

Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Time frame: Day 90

3 secondary outcomes

Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Time frame: Day 90
Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Time frame: Day 28
Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Time frame: Day 28

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 5 Sep 2024.
Derived from this study: PubMed 40304564Liangpunsakul S, Krebs WB, Kwong AJ, Kwo PY, Brown RS Jr, Lin W, Sussman NL. The impact of liver transplantation on endpoint selection in alcohol-associated hepatitis trials. Hepatol Commun. 2025 Apr 30;9(5):e0709. doi: 10.1097/HC9.0000000000000709. eCollection 2025 May 1.
Derived from this study: PubMed 39873544Shiffman M, Da B, Goel A, Kwong A, Stein L, Moreno C, Nicoll A, Mehta A, Louvet A, Flamm S, Pyrsopoulos N, Satapathy S, Kuo A, Ganger D, Aloman C, Strasser SI, Tse E, Russo MW, Rockey D, Gray M, Mitchell M, Thursz M, Krebs W, Scott D, Blevins C, Ellis D, Brown J, Sussman N, Lin W. Larsucosterol for the Treatment of Alcohol-Associated Hepatitis. NEJM Evid. 2025 Feb;4(2):EVIDoa2400243. doi: 10.1056/EVIDoa2400243. Epub 2025 Jan 28.
Individual participant dataSharing planned: No

Related trials for Alcoholic Hepatitis

RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Hepatitis
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
RecruitingPhase 2
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States
Cirrhosis, Cirrhosis, Liver

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.

Robert Gordon, MD, FACS study director

CTI Clinical Trial and Consulting Services

68 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DUR-928 30 mg and DUR-928 90 mg in people with Alcoholic Hepatitis, run by Durect at 68 sites in 6 countries.

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 14 inclusion and 17 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Australia, United Kingdom, France, Belgium and 1 more country. 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. Some participants in this study may receive a placebo. 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?

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?

Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo. (time frame: Day 90). 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 NCT04563026, 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 5 Sep 2024.