RECRUITING
Phase 3
ClinicalTrials.gov
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Sponsor: Bausch Health Americas, Inc. • ClinicalTrials.gov ID: NCT07428538
Registry updated: 2026-10-15
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Check Eligibility →Description
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.
Interventions
-
Larsucosterol
(Drug)
Larsucosterol intravenous infusion.
-
Placebo
(Drug)
Matching-placebo (sterile water for injection) intravenous infusion.
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.
Conditions
Hepatitis
Locations
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
- University of South Alabama — Mobile, Alabama, United States
- Banner - University Medical Center, Phoenix, Arizona — Phoenix, Arizona, United States
- Mayo Clinic - Phoenix — Phoenix, Arizona, United States
- Southern California GI & Liver Centers - Coronado — Coronado, California, United States
- Fresno Clinical Research Center (FCRC) — Fresno, California, United States
- Scripps — La Jolla, California, United States
- UC San Diego School of Medicine — La Jolla, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- UCLA Health - Ronald Reagan Medical Center — Los Angeles, California, United States
- Sutter Health — Palo Alto, California, United States
- Stanford Medicine - Clinical and Translational Research Unit - Redwood City — Redwood City, California, United States
- University of California at Davis Medical Center — Sacramento, California, United States
- Yale School of Medicine — New Haven, Connecticut, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- University of Florida (UF) — Gainesville, Florida, United States
- Mayo Clinic — Jacksonville, Florida, United States
- University of Miami — Miami, Florida, United States
- Reliant Medical Research — Miami, Florida, United States
- AdventHealth Transplant Institute — Orlando, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- AdventHealth Medical Campus — Tampa, Florida, United States
- Piedmont Atlanta Hospital - Piedmont Transplant Institute — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Loyola University Medical Center (LUMC) — Maywood, Illinois, United States
- Indiana Institute for Medical Research (Indiana VA) — Indianapolis, Indiana, United States
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
- University of Kentucky -Chandler Medical Center — Lexington, Kentucky, United States
- Robley Rex VA Medical Center — Louisville, Kentucky, United States
- Tulane University Health Sciences Center - Tulane Avenue — New Orleans, Louisiana, United States
- Maine Medical Center - Bramhall Campus — Portland, Maine, United States
- Mercy Medical Center - The Institute for Digestive Health and Liver Disease — Baltimore, Maryland, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston University School of Medicine — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- UMass Chan Medical School — Worcester, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Henry Ford Hospital System — Detroit, Michigan, United States
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- University of Nevada Las Vegas — Las Vegas, Nevada, United States
- Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River — Camden, New Jersey, United States
- Rutgers University New Jersey Medical School — Newark, New Jersey, United States
- University of New Mexico (UNM) Hospital — Albuquerque, New Mexico, United States
- Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases — Manhasset, New York, United States
- Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic — New York, New York, United States
- NYU Langone Health — New York, New York, United States
- NewYork-Presbyterian/Weill Cornell Medical Center — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Westchester Medical Center — Valhalla, New York, United States
- University of North Carolina (UNC Hospitals) — Chapel Hill, North Carolina, United States
- Levine Cancer Institute / Atrium Health — Charlotte, North Carolina, United States
- Duke University Hospital — Durham, North Carolina, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- The Ohio State University Wexner Medical Center (OSUWMC) — Columbus, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Penn State Health, Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
- VA Medical Center - Philadelphia — Philadelphia, Pennsylvania, United States
- University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Temple University Hospital — Philadelphia, Pennsylvania, United States
- Einstein Medical Center Philadelphia — Philadelphia, Pennsylvania, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Ralph H. Johnson Department of Veterans Affairs Medical Center — Charleston, South Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Galen Medical Group - Galen Hepatology — Chattanooga, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States
- Baylor Scott White Research Institute - Dallas — Dallas, Texas, United States
- North Texas Gastroenterology — Denton, Texas, United States
- Baylor Scott & White All Saints Medical Center - Fort Worth — Fort Worth, Texas, United States
- Baylor College of Medicine (BCM) - Baylor Clinic — Houston, Texas, United States
- Clinical Trial Network - Houston — Houston, Texas, United States
- Methodist Healthcare - Methodist Hospital Specialty and Transplant — San Antonio, Texas, United States
- Baylor Scott White Research Institute - Temple — Temple, Texas, United States
- Intermountain Transplant Clinic — Murray, Utah, United States
- University of Utah Health - University of Utah — Salt Lake City, Utah, United States
- University of Virginia Health — Charlottesville, Virginia, United States
- Bon Secours Liver Institute of Richmond — Richmond, Virginia, United States
- Richmond VA Medical Center — Richmond, Virginia, United States
- Virginia Mason Medical Center (VMMC) - Seattle — Seattle, Washington, United States
- Swedish Medical Center — Seattle, Washington, United States
- UW Medicine-Harborview Medical Center — Seattle, Washington, United States
- Marshall Health — Huntington, West Virginia, United States
- University of Wisconsin-Madison — Madison, Wisconsin, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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