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HepatitisPhase 3NCT07428538

Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)

A Phase 3 study testing Larsucosterol in people with Hepatitis, run by Bausch Health Americas, Inc. at 92 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (>=) 32 and Model for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis
What is being tested?
Larsucosterol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
92 sitesUnited States
Study dates
29 Jan 2026to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • A participant will be eligible for inclusion in this study if he/she meets all the following criteria:
  • Able to provide written informed consent (either from participant or participant's legally acceptable representative).
  • Onset of jaundice within 8 weeks before hospital admission.
  • Average daily consumption of greater than (>) 40 (females) or >60 (males) grams alcohol for 6 months or longer, with less than (<) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.
  • The determination of AH will be based on typical serum chemistry (as determined by local laboratory):
  • Serum total bilirubin >3.0 milligrams per deciliter (mg/dL) (required at randomization)
Show all 19Show fewer
  • ALT <400 international unit per Liter (IU/L) (required at randomization)
  • 50 <AST <400 IU/L
  • AST <400 IU/L (required at randomization)
  • AST >50 IU/L (at any time since current hospital admission or leading to this current hospitalization)
  • AST/ALT >1.5 (at any time since current hospital admission or leading to this current hospitalization)
  • Maddrey discriminant function (MDF) >=32, assuming a control prothrombin time of 12 seconds.
  • NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time/INR.
  • Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).
  • Male or female participants 18 years of age or older.
  • Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills ("The Pill") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.
  • Male participants must agree to use a medically acceptable method of contraception/birth control and refrain from sperm donation throughout the 90-day portion of the study.
  • Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
  • Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s)

Who cannot join

  • A participant will be excluded from the study if he or she meets any of the following criteria:
  • Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.
  • NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial
  • Participants 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], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
  • Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
Show all 42Show fewer
  • Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.
  • Participants with systemic fungal infection of any kind cannot be considered for this trial.
  • Serum creatinine >2.5 mg/dL.
  • Participants undergoing continuous veno-venous hemodialysis (CVVH).
  • Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded.
  • TIPS insertion or variceal embolization within the last 4 weeks.
  • Known portal vein occlusion.
  • 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. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation.
  • Stage >=3 hepatic encephalopathy by West Haven criteria.
  • Participants with medical conditions that are expected to pose a high risk of short-term (less than or equal to [<=] 90 days) mortality unrelated to alcohol-associated hepatitis, or that may confound assessment of 90-day survival in the Investigator's judgement. Examples include, but are not limited to:
  • Severe concomitant cardiopulmonary disease (e.g., New York Heart Association [NYHA] Class III or IV heart failure)
  • Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc >=500 msec, or high-grade AV block)
  • Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease [GOLD] Stage III or IV chronic obstructive pulmonary disease [COPD])
  • End-stage renal disease requiring chronic, ongoing dialysis
  • Severe uncontrolled endocrine or metabolic disorders
  • Severe psychiatric illness likely to interfere with study participation
  • Hypotension/shock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure [MAP] <60 millimeter of mercury (mmHg), despite adequate fluid resuscitation and cardiac output)
  • Other concomitant cause(s) of liver disease as a result of:
  • Autoimmune liver disease
  • Ischemic hepatitis
  • Wilson disease or alpha 1 antitrypsin deficiency
  • Vascular liver disease (e.g., Budd-Chiari)
  • Drug induced liver disease
  • Surface antigen positive hepatitis B (HBsAg+). NOTE: Participants with isolated core antibody (anti-HBc) or who are on stable antiviral medication with known viral suppression are not excluded, but appropriate HBV prophylaxis should be considered if steroid dosing >4 weeks is anticipated.
  • Acute hepatitis A (if test performed per SOC)
  • Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded
  • Acute hepatitis E (if test performed per SOC)
  • Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)
  • Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
  • Existing or intended pregnancy or breast feeding.
  • Participation in another interventional clinical trial within 30 days of Screening.
  • History of organ transplantation other than corneal transplant.
  • Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.
  • Participant listed for liver transplant (LT) prior to study drug administration.
  • Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.

Trial locations and contacts

92 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Varsha Bhatt, PhD contact

707-230-1712

varsha.bhatt@bauschhealth.com

Alycia Olsen contact

201-846-8376

Alycia.Olsen@bauschhealth.com

92 sites in 1 country

United States92 sites, 91 recruiting

  • University of New Mexico (UNM) Hospital

    Albuquerque, New Mexico, 87106-4713

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Piedmont Atlanta Hospital - Piedmont Transplant Institute

    Atlanta, Georgia, 30309

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Not yet recruiting

  • Augusta University

    Augusta, Georgia, 30912

    Not yet recruiting

  • Mercy Medical Center - The Institute for Digestive Health and Liver Disease

    Baltimore, Maryland, 21202

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Not yet recruiting

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Not yet recruiting

  • Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River

    Camden, New Jersey, 08103

    Not yet recruiting

  • University of North Carolina (UNC Hospitals)

    Chapel Hill, North Carolina, 27514

    Not yet recruiting

  • Ralph H. Johnson Department of Veterans Affairs Medical Center

    Charleston, South Carolina, 29401

    Not yet recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Levine Cancer Institute / Atrium Health

    Charlotte, North Carolina, 28204

    Recruiting

  • University of Virginia Health

    Charlottesville, Virginia, 22908

    Recruiting

  • Galen Medical Group - Galen Hepatology

    Chattanooga, Tennessee, 37402

    Not yet recruiting

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60601

    Not yet recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44114

    Not yet recruiting

  • The Ohio State University Wexner Medical Center (OSUWMC)

    Columbus, Ohio, 43210

    Recruiting

  • Southern California GI & Liver Centers - Coronado

    Coronado, California, 92118

    Withdrawn

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

    Recruiting

  • Baylor Scott White Research Institute - Dallas

    Dallas, Texas, 75246

    Not yet recruiting

  • North Texas Gastroenterology

    Denton, Texas, 75149-7418

    Not yet recruiting

  • Henry Ford Hospital System

    Detroit, Michigan, 48202

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Not yet recruiting

  • Baylor Scott & White All Saints Medical Center - Fort Worth

    Fort Worth, Texas, 76104

    Not yet recruiting

  • Fresno Clinical Research Center (FCRC)

    Fresno, California, 93730

    Not yet recruiting

  • University of Florida (UF)

    Gainesville, Florida, 32608

    Not yet recruiting

  • Penn State Health, Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • Baylor College of Medicine (BCM) - Baylor Clinic

    Houston, Texas, 77030

    Recruiting

  • Clinical Trial Network - Houston

    Houston, Texas, 77074

    Recruiting

  • Marshall Health

    Huntington, West Virginia, 25701

    Not yet recruiting

  • Indiana Institute for Medical Research (Indiana VA)

    Indianapolis, Indiana, 46202

    Not yet recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32202

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Not yet recruiting

  • Scripps

    La Jolla, California, 92037

    Not yet recruiting

  • UC San Diego School of Medicine

    La Jolla, California, 92093

    Not yet recruiting

  • University of Nevada Las Vegas

    Las Vegas, Nevada, 89154-9900

    Not yet recruiting

  • University of Kentucky -Chandler Medical Center

    Lexington, Kentucky, 40507

    Not yet recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • UCLA Health - Ronald Reagan Medical Center

    Los Angeles, California, 90095

    Not yet recruiting

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

    Not yet recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53703

    Not yet recruiting

  • Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases

    Manhasset, New York, 11030

    Recruiting

  • Loyola University Medical Center (LUMC)

    Maywood, Illinois, 60153

    Not yet recruiting

  • University of Miami

    Miami, Florida, 33136

    Not yet recruiting

  • Reliant Medical Research

    Miami, Florida, 33165

    Not yet recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55414-2924

    Not yet recruiting

  • University of South Alabama

    Mobile, Alabama, 36608-3271

    Not yet recruiting

  • Intermountain Transplant Clinic

    Murray, Utah, 84107

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Not yet recruiting

  • Yale School of Medicine

    New Haven, Connecticut, 06510

    Not yet recruiting

  • Tulane University Health Sciences Center - Tulane Avenue

    New Orleans, Louisiana, 70112

    Recruiting

  • Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic

    New York, New York, 10007

    Not yet recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • NewYork-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065

    Not yet recruiting

  • Rutgers University New Jersey Medical School

    Newark, New Jersey, 07103-2425

    Recruiting

  • AdventHealth Transplant Institute

    Orlando, Florida, 32804

    Not yet recruiting

  • Sutter Health

    Palo Alto, California, 94109

    Recruiting

  • VA Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104-4551

    Recruiting

  • University of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Not yet recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Not yet recruiting

  • Einstein Medical Center Philadelphia

    Philadelphia, Pennsylvania, 19141

    Not yet recruiting

  • Banner - University Medical Center, Phoenix, Arizona

    Phoenix, Arizona, 85006

    Recruiting

  • Mayo Clinic - Phoenix

    Phoenix, Arizona, 85054

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-3232

    Not yet recruiting

  • Maine Medical Center - Bramhall Campus

    Portland, Maine, 04102-3134

    Not yet recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Not yet recruiting

  • Stanford Medicine - Clinical and Translational Research Unit - Redwood City

    Redwood City, California, 94063

    Not yet recruiting

  • Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

    Recruiting

  • Richmond VA Medical Center

    Richmond, Virginia, 23249

    Recruiting

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Not yet recruiting

  • University of California at Davis Medical Center

    Sacramento, California, 95816

    Recruiting

  • University of Utah Health - University of Utah

    Salt Lake City, Utah, 84132

    Not yet recruiting

  • Methodist Healthcare - Methodist Hospital Specialty and Transplant

    San Antonio, Texas, 78229

    Recruiting

  • Virginia Mason Medical Center (VMMC) - Seattle

    Seattle, Washington, 98101

    Not yet recruiting

  • Swedish Medical Center

    Seattle, Washington, 98104

    Not yet recruiting

  • UW Medicine-Harborview Medical Center

    Seattle, Washington, 98104

    Not yet recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Recruiting

  • AdventHealth Medical Campus

    Tampa, Florida, 33613

    Not yet recruiting

  • Baylor Scott White Research Institute - Temple

    Temple, Texas, 76508

    Not yet recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Not yet recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Not yet recruiting

  • UMass Chan Medical School

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

About this study

Official title: RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)

The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.

Conditions
Hepatitis
Being tested
Larsucosterol, Placebo
Keywords
Alcoholic hepatitis, alcohol-associated liver disease (ALD), Liver transplant (LT), Alcohol-associated hepatitis (AH)
Medical subject headings
Hepatitis, Hepatitis, Alcoholic

What participants receive

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

  • LarsucosterolDrug

    Also called DUR928, DV928

    Larsucosterol intravenous infusion.

  • PlaceboDrug

    Matching-placebo (sterile water for injection) intravenous infusion.

Study groups in NCT07428538
Study groupRoleWhat they receive
Larsucosterol 30 mgExperimentalParticipants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
Receives: Drug: Larsucosterol
PlaceboPlacebo comparatorParticipants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.
Receives: Drug: Placebo

What is being measured

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

  1. Transplant Free Survival up to Day 90

    Measured: Up to Day 90

Secondary outcomes (9)

  1. Overall Survival at Day 90

    Measured: Day 90

  2. Time to Death up to Day 90

    Measured: Up to Day 90

  3. Number of Participants with Days Alive and Out of Hospital up to Day 90

    Measured: Up to Day 90

  4. Time to First Post Discharge All-cause Hospitalization up to Day 90

    Measured: Up to Day 90

  5. Number of Participants with Intensive Care Unit (ICU) Utilization up to Day 90

    Measured: Up to Day 90

  6. Change from Baseline in Model for End-Stage Liver Disease (MELD) Score

    Measured: Day 7 up to Day 180

  7. Change from Baseline in Bilirubin Levels

    Measured: Up to Day 180

  8. Transplant Free Survival up to Day 180

    Measured: Up to Day 180

  9. Overall Survival at Day 180

    Measured: Day 180

Timeline

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

  1. First posted23 Feb 2026
  2. Study start29 Jan 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07428538
Sponsor's protocol ID
LCAH3141
Status last verified
Oct 2026
First submitted
19 Feb 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Larsucosterol in people with Hepatitis, run by Bausch Health Americas, Inc. at 92 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 19 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 15 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 92 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Varsha Bhatt, PhD (707-230-1712, varsha.bhatt@bauschhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transplant Free Survival up to Day 90 (time frame: Up to 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 NCT07428538.

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 15 Oct 2026.

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