🔎 Trials Near Me

Home › Hepatitis › NCT07428538

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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria-

A participant will be eligible for inclusion in this study if he/she meets all the following criteria:

1. Able to provide written informed consent (either from participant or participant's legally acceptable representative).
2. Onset of jaundice within 8 weeks before hospital admission.
3. 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.
4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory):

   1. Serum total bilirubin \>3.0 milligrams per deciliter (mg/dL) (required at randomization)
   2. ALT \<400 international unit per Liter (IU/L) (required at randomization)
   3. 50 \<AST \<400 IU/L
   4. AST \<400 IU/L (required at randomization)
   5. AST \>50 IU/L (at any time since current hospital admission or leading to this current hospitalization)
   6. AST/ALT \>1.5 (at any time since current hospital admission or leading to this current hospitalization)
5. 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.
6. Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).
7. Male or female participants 18 years of age or older.
8. 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.
9. 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.
10. Participants must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.
11. Participants must be dosed within 9 calendar days (216 hours) of hospital admission inclusive of time spent in other hospital(s)

Exclusion Criteria-

A participant will be excluded from the study if he or she meets any of the following criteria:

1. 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
2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
3. 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).

   1. 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.
   2. 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.
   3. Participants with systemic fungal infection of any kind cannot be considered for this trial.
4. Serum creatinine \>2.5 mg/dL.
5. Participants undergoing continuous veno-venous hemodialysis (CVVH).
6. 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.
7. TIPS insertion or variceal embolization within the last 4 weeks.
8. Known portal vein occlusion.
9. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
10. 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.
11. Stage \>=3 hepatic encephalopathy by West Haven criteria.
12. 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:

    1. Severe concomitant cardiopulmonary disease (e.g., New York Heart Association \[NYHA\] Class III or IV heart failure)
    2. Clinically significant cardiac arrhythmia (e.g., sustained ventricular tachycardia, unmanaged atrial fibrillation, QTc \>=500 msec, or high-grade AV block)
    3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Stage III or IV chronic obstructive pulmonary disease \[COPD\])
    4. End-stage renal disease requiring chronic, ongoing dialysis
    5. Severe uncontrolled endocrine or metabolic disorders
    6. Severe psychiatric illness likely to interfere with study participation
    7. 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)
13. Other concomitant cause(s) of liver disease as a result of:

    1. Autoimmune liver disease
    2. Ischemic hepatitis
    3. Wilson disease or alpha 1 antitrypsin deficiency
    4. Vascular liver disease (e.g., Budd-Chiari)
    5. Drug induced liver disease
    6. 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.
    7. Acute hepatitis A (if test performed per SOC)
    8. 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
    9. Acute hepatitis E (if test performed per SOC)
    10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)
14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
15. Existing or intended pregnancy or breast feeding.
16. Participation in another interventional clinical trial within 30 days of Screening.
17. History of organ transplantation other than corneal transplant.
18. 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.
19. Participant listed for liver transplant (LT) prior to study drug administration.
20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.

About the study

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.

What is being tested

Sponsor: Bausch Health Americas, Inc. · Participants: 350 · Started: Jan 29, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07428538

Locations in the U.S.

AlabamaUniversity of Alabama at Birmingham (UAB) Hospital, Birmingham
University of South Alabama, Mobile (Not yet recruiting)
ArizonaBanner - University Medical Center, Phoenix, Arizona, Phoenix
Mayo Clinic - Phoenix, Phoenix (Not yet recruiting)
CaliforniaScripps, La Jolla (Not yet recruiting)
Cedars Sinai Medical Center, Los Angeles
UCLA Health - Ronald Reagan Medical Center, Los Angeles (Not yet recruiting)
Stanford Medicine - Clinical and Translational Research Unit - Redwood City, Redwood City (Not yet recruiting)
University of California at Davis Medical Center, Sacramento
Sutter Health, San Francisco
ConnecticutYale School of Medicine, New Haven (Not yet recruiting)
District of ColumbiaGeorgetown University Medical Center, Washington D.C. (Not yet recruiting)
FloridaMayo Clinic, Jacksonville (Not yet recruiting)
Reliant Medical Research, Miami (Not yet recruiting)
University of Miami, Miami (Not yet recruiting)
AdventHealth Transplant Institute, Orlando (Not yet recruiting)
AdventHealth Medical Campus, Tampa (Not yet recruiting)
Tampa General Hospital, Tampa (Not yet recruiting)
GeorgiaPiedmont Atlanta Hospital - Piedmont Transplant Institute, Atlanta
Augusta University, Augusta (Not yet recruiting)
IllinoisNorthwestern University - Feinberg School of Medicine, Chicago (Not yet recruiting)
Rush University Medical Center, Chicago (Not yet recruiting)
Loyola University Medical Center (LUMC), Maywood (Not yet recruiting)
IndianaIndiana Institute for Medical Research (Indiana VA), Indianapolis (Not yet recruiting)
IowaUniversity of Iowa Hospitals & Clinics, Iowa City
KentuckyUniversity of Kentucky -Chandler Medical Center, Lexington (Not yet recruiting)
Robley Rex VA Medical Center, Louisville (Not yet recruiting)
LouisianaTulane University Health Sciences Center - Tulane Avenue, New Orleans
MaineMaine Medical Center - Bramhall Campus, Portland (Not yet recruiting)
MarylandJohns Hopkins Hospital, Baltimore (Not yet recruiting)
Mercy Medical Center - The Institute for Digestive Health and Liver Disease, Baltimore
MassachusettsBeth Israel Deaconess Medical Center, Boston (Not yet recruiting)
Boston University School of Medicine, Boston (Not yet recruiting)
Massachusetts General Hospital, Boston (Not yet recruiting)
Tufts Medical Center, Boston (Not yet recruiting)
UMass Chan Medical School, Worcester (Not yet recruiting)
MichiganUniversity of Michigan, Ann Arbor
Henry Ford Hospital System, Detroit (Not yet recruiting)
MinnesotaUniversity of Minnesota Medical Center, Minneapolis (Not yet recruiting)
MissouriSaint Luke's Hospital of Kansas City, Kansas City (Not yet recruiting)
NevadaUniversity of Nevada Las Vegas, Las Vegas (Not yet recruiting)
New JerseyVirtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River, Camden (Not yet recruiting)
Rutgers University New Jersey Medical School, Newark (Not yet recruiting)
New MexicoUniversity of New Mexico (UNM) Hospital, Albuquerque
New YorkNorthwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases, Manhasset
Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic, New York (Not yet recruiting)
NYU Langone Health, New York (Not yet recruiting)
University of Rochester Medical Center, Rochester (Not yet recruiting)
Montefiore Medical Center, The Bronx (Not yet recruiting)
North CarolinaUniversity of North Carolina (UNC Hospitals), Chapel Hill (Not yet recruiting)
Levine Cancer Institute / Atrium Health, Charlotte (Not yet recruiting)
Duke University Hospital, Durham (Not yet recruiting)
OhioCleveland Clinic, Cleveland (Not yet recruiting)
University Hospitals Cleveland Medical Center, Cleveland (Not yet recruiting)
The Ohio State University Wexner Medical Center (OSUWMC), Columbus
OregonOregon Health & Science University, Portland (Not yet recruiting)
PennsylvaniaPenn State Health, Milton S. Hershey Medical Center, Hershey
Einstein Medical Center Philadelphia, Philadelphia (Not yet recruiting)
Temple University Hospital, Philadelphia (Not yet recruiting)
Thomas Jefferson University Hospital, Philadelphia (Not yet recruiting)
University of Pennsylvania Hospital, Philadelphia (Not yet recruiting)
VA Medical Center - Philadelphia, Philadelphia (Not yet recruiting)
University of Pittsburgh, Pittsburgh (Not yet recruiting)
South CarolinaMedical University of South Carolina, Charleston
Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston (Not yet recruiting)
TennesseeGalen Medical Group - Galen Hepatology, Chattanooga (Not yet recruiting)
Vanderbilt University Medical Center, Nashville (Not yet recruiting)
TexasBaylor Scott White Research Institute - Dallas, Dallas (Not yet recruiting)
The Liver Institute at Methodist Dallas Medical Center, Dallas
North Texas Gastroenterology, Denton (Not yet recruiting)
Baylor Scott & White All Saints Medical Center - Fort Worth, Fort Worth (Not yet recruiting)
Baylor College of Medicine (BCM) - Baylor Clinic, Houston
Clinical Trial Network - Houston, Houston (Not yet recruiting)
Methodist Healthcare - Methodist Hospital Specialty and Transplant, San Antonio (Not yet recruiting)
Baylor Scott White Research Institute - Temple, Temple (Not yet recruiting)
UtahIntermountain Transplant Clinic, Murray
University of Utah Health - University of Utah, Salt Lake City (Not yet recruiting)
VirginiaUniversity of Virginia Health, Charlottesville
Bon Secours Liver Institute of Richmond, Richmond
Richmond VA Medical Center, Richmond
WashingtonSwedish Medical Center, Seattle (Not yet recruiting)
UW Medicine-Harborview Medical Center, Seattle (Not yet recruiting)
Virginia Mason Medical Center (VMMC) - Seattle, Seattle (Not yet recruiting)
West VirginiaMarshall Health, Huntington (Not yet recruiting)
WisconsinUniversity of Wisconsin-Madison, Madison (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.