此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

评估Larsucosterol在酒精性肝炎（AH）参与者中的安全性和有效性的研究

2026年10月14日 更新者：Bausch Health Americas, Inc.

RE-AHFIRM（拉苏可斯醇治疗酒精相关性肝炎的随机化研究，旨在确认治疗的安全性和有效性）

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

350

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • 招聘中
        • University of Alabama at Birmingham (UAB) Hospital
      • Mobile、Alabama、美国、36608-3271
        • 尚未招聘
        • University of South Alabama
    • Arizona
      • Phoenix、Arizona、美国、85054
        • 招聘中
        • Mayo Clinic - Phoenix
      • Phoenix、Arizona、美国、85006
        • 招聘中
        • Banner - University Medical Center, Phoenix, Arizona
    • California
      • Coronado、California、美国、92118
        • 撤销
        • Southern California GI & Liver Centers - Coronado
      • Fresno、California、美国、93730
        • 尚未招聘
        • Fresno Clinical Research Center (FCRC)
      • La Jolla、California、美国、92037
        • 尚未招聘
        • Scripps
      • La Jolla、California、美国、92093
        • 尚未招聘
        • UC San Diego School of Medicine
      • Los Angeles、California、美国、90048
        • 招聘中
        • Cedars Sinai Medical Center
      • Los Angeles、California、美国、90095
        • 尚未招聘
        • UCLA Health - Ronald Reagan Medical Center
      • Palo Alto、California、美国、94109
        • 招聘中
        • Sutter Health
      • Redwood City、California、美国、94063
        • 尚未招聘
        • Stanford Medicine - Clinical and Translational Research Unit - Redwood City
      • Sacramento、California、美国、95816
        • 招聘中
        • University of California at Davis Medical Center
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • 尚未招聘
        • Yale School of Medicine
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
        • 尚未招聘
        • Georgetown University Medical Center
    • Florida
      • Gainesville、Florida、美国、32608
        • 尚未招聘
        • University of Florida (UF)
      • Jacksonville、Florida、美国、32202
        • 招聘中
        • Mayo Clinic
      • Miami、Florida、美国、33136
        • 尚未招聘
        • University of Miami
      • Miami、Florida、美国、33165
        • 尚未招聘
        • Reliant Medical Research
      • Orlando、Florida、美国、32804
        • 尚未招聘
        • AdventHealth Transplant Institute
      • Tampa、Florida、美国、33606
        • 招聘中
        • Tampa General Hospital
      • Tampa、Florida、美国、33613
        • 尚未招聘
        • AdventHealth Medical Campus
    • Georgia
      • Atlanta、Georgia、美国、30322
        • 尚未招聘
        • Emory University Hospital
      • Atlanta、Georgia、美国、30309
        • 招聘中
        • Piedmont Atlanta Hospital - Piedmont Transplant Institute
      • Augusta、Georgia、美国、30912
        • 尚未招聘
        • Augusta University
    • Illinois
      • Chicago、Illinois、美国、60612
        • 招聘中
        • Rush University Medical Center
      • Chicago、Illinois、美国、60601
        • 尚未招聘
        • Northwestern University - Feinberg School of Medicine
      • Maywood、Illinois、美国、60153
        • 尚未招聘
        • Loyola University Medical Center (LUMC)
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 尚未招聘
        • Indiana Institute for Medical Research (Indiana VA)
    • Iowa
      • Iowa City、Iowa、美国、52242
        • 招聘中
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington、Kentucky、美国、40507
        • 尚未招聘
        • University of Kentucky -Chandler Medical Center
      • Louisville、Kentucky、美国、40206
        • 尚未招聘
        • Robley Rex VA Medical Center
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • 招聘中
        • Tulane University Health Sciences Center - Tulane Avenue
    • Maine
      • Portland、Maine、美国、04102-3134
        • 尚未招聘
        • Maine Medical Center - Bramhall Campus
    • Maryland
      • Baltimore、Maryland、美国、21287
        • 尚未招聘
        • Johns Hopkins Hospital
      • Baltimore、Maryland、美国、21202
        • 招聘中
        • Mercy Medical Center - The Institute for Digestive Health and Liver Disease
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 招聘中
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02118
        • 招聘中
        • Boston University School of Medicine
      • Boston、Massachusetts、美国、02215
        • 尚未招聘
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、美国、02111
        • 尚未招聘
        • Tufts Medical Center
      • Worcester、Massachusetts、美国、01655
        • 招聘中
        • UMass Chan Medical School
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • 招聘中
        • University of Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Hospital System
    • Minnesota
      • Minneapolis、Minnesota、美国、55414-2924
        • 尚未招聘
        • University of Minnesota Medical Center
    • Missouri
      • Kansas City、Missouri、美国、64111
        • 尚未招聘
        • Saint Luke's Hospital of Kansas City
    • Nevada
      • Las Vegas、Nevada、美国、89154-9900
        • 尚未招聘
        • University of Nevada Las Vegas
    • New Jersey
      • Camden、New Jersey、美国、08103
        • 尚未招聘
        • Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River
      • Newark、New Jersey、美国、07103-2425
        • 招聘中
        • Rutgers University New Jersey Medical School
    • New Mexico
      • Albuquerque、New Mexico、美国、87106-4713
        • 招聘中
        • University of New Mexico (UNM) Hospital
    • New York
      • Manhasset、New York、美国、11030
        • 招聘中
        • Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Health
      • New York、New York、美国、10065
        • 尚未招聘
        • NewYork-Presbyterian/Weill Cornell Medical Center
      • New York、New York、美国、10007
        • 尚未招聘
        • Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic
      • Rochester、New York、美国、14642
        • 尚未招聘
        • University of Rochester Medical Center
      • The Bronx、New York、美国、10467
        • 招聘中
        • Montefiore Medical Center
      • Valhalla、New York、美国、10595
        • 尚未招聘
        • Westchester Medical Center
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • 尚未招聘
        • University of North Carolina (UNC Hospitals)
      • Charlotte、North Carolina、美国、28204
        • 招聘中
        • Levine Cancer Institute / Atrium Health
      • Durham、North Carolina、美国、27710
        • 尚未招聘
        • Duke University Hospital
    • Ohio
      • Cleveland、Ohio、美国、44106
        • 尚未招聘
        • University Hospitals Cleveland Medical Center
      • Cleveland、Ohio、美国、44114
        • 尚未招聘
        • Cleveland Clinic
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The Ohio State University Wexner Medical Center (OSUWMC)
    • Oregon
      • Portland、Oregon、美国、97239
        • 尚未招聘
        • Oregon Health & Science University
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • 招聘中
        • Penn State Health, Milton S. Hershey Medical Center
      • Philadelphia、Pennsylvania、美国、19140
        • 尚未招聘
        • Temple University Hospital
      • Philadelphia、Pennsylvania、美国、19104
        • 招聘中
        • University of Pennsylvania Hospital
      • Philadelphia、Pennsylvania、美国、19107
        • 尚未招聘
        • Thomas Jefferson University Hospital
      • Philadelphia、Pennsylvania、美国、19104-4551
        • 招聘中
        • VA Medical Center - Philadelphia
      • Philadelphia、Pennsylvania、美国、19141
        • 尚未招聘
        • Einstein Medical Center Philadelphia
      • Pittsburgh、Pennsylvania、美国、15213-3232
        • 尚未招聘
        • University of Pittsburgh
    • South Carolina
      • Charleston、South Carolina、美国、29425
        • 招聘中
        • Medical University of South Carolina
      • Charleston、South Carolina、美国、29401
        • 尚未招聘
        • Ralph H. Johnson Department of Veterans Affairs Medical Center
    • Tennessee
      • Chattanooga、Tennessee、美国、37402
        • 尚未招聘
        • Galen Medical Group - Galen Hepatology
      • Nashville、Tennessee、美国、37232
        • 尚未招聘
        • Vanderbilt University Medical Center
    • Texas
      • Dallas、Texas、美国、75203
        • 招聘中
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas、Texas、美国、75246
        • 尚未招聘
        • Baylor Scott White Research Institute - Dallas
      • Denton、Texas、美国、75149-7418
        • 尚未招聘
        • North Texas Gastroenterology
      • Fort Worth、Texas、美国、76104
        • 尚未招聘
        • Baylor Scott & White All Saints Medical Center - Fort Worth
      • Houston、Texas、美国、77074
        • 招聘中
        • Clinical Trial Network - Houston
      • Houston、Texas、美国、77030
        • 招聘中
        • Baylor College of Medicine (BCM) - Baylor Clinic
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Methodist Healthcare - Methodist Hospital Specialty and Transplant
      • Temple、Texas、美国、76508
        • 尚未招聘
        • Baylor Scott White Research Institute - Temple
    • Utah
      • Murray、Utah、美国、84107
        • 招聘中
        • Intermountain Transplant Clinic
      • Salt Lake City、Utah、美国、84132
        • 尚未招聘
        • University of Utah Health - University of Utah
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • 招聘中
        • University of Virginia Health
      • Richmond、Virginia、美国、23226
        • 招聘中
        • Bon Secours Liver Institute of Richmond
      • Richmond、Virginia、美国、23249
        • 招聘中
        • Richmond VA Medical Center
    • Washington
      • Seattle、Washington、美国、98104
        • 尚未招聘
        • Swedish Medical Center
      • Seattle、Washington、美国、98101
        • 尚未招聘
        • Virginia Mason Medical Center (VMMC) - Seattle
      • Seattle、Washington、美国、98104
        • 尚未招聘
        • UW Medicine-Harborview Medical Center
    • West Virginia
      • Huntington、West Virginia、美国、25701
        • 尚未招聘
        • Marshall Health
    • Wisconsin
      • Madison、Wisconsin、美国、53703
        • 尚未招聘
        • University of Wisconsin-Madison

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Larsucosterol 30 mg

Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
药品：Larsucosterol

Larsucosterol intravenous infusion.

其他名称：
  • DUR928
  • DV928
安慰剂比较：Placebo

Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.
药品：Placebo

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

研究衡量的是什么？

主要结果指标

结果测量
大体时间
移植无生存期至第90天
大体时间：至第90天
至第90天

次要结果测量

结果测量
大体时间
90天总生存期
大体时间：第90天
第90天
第90天内的死亡时间
大体时间：至第90天
至第90天
第 90 天时存活且未住院的参与者人数
大体时间：截至第 90 天
截至第 90 天
出院后首次全因住院时间（至第90天）
大体时间：截至第90天
截至第90天
截至第90天入住重症监护病房（ICU）的参与者人数
大体时间：至第90天
至第90天
Change from Baseline in Model for End-Stage Liver Disease (MELD) Score
大体时间：第7天至第180天
第7天至第180天
胆红素水平相对于基线的变化
大体时间：截至第180天
截至第180天
移植后180天内无移植生存期
大体时间：至第 180 天
至第 180 天
第180天总生存期
大体时间：第 180 天
第 180 天

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bausch Health Americas, Inc.

合作者

Durect

调查人员

  • 研究主任：Varsha Bhatt, PhD、Bausch Health Americas, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月29日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年2月19日

首先提交符合 QC 标准的

2026年2月19日

首次发布 (实际的)

2026年2月23日

研究记录更新

最后更新发布 (实际的)

2026年10月15日

上次提交的符合 QC 标准的更新

2026年10月14日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LCAH3141

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅