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History of Changes for Study: NCT04563026
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
Latest version (submitted February 23, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 18, 2020 None (earliest Version on record)
2 February 1, 2021 Recruitment Status, Study Status and Contacts/Locations
3 March 22, 2021 Contacts/Locations and Study Status
4 May 11, 2021 Contacts/Locations and Study Status
5 June 11, 2021 Contacts/Locations and Study Status
6 July 26, 2021 Contacts/Locations and Study Status
7 October 11, 2021 Contacts/Locations and Study Status
8 December 9, 2021 Contacts/Locations and Study Status
9 January 28, 2022 Contacts/Locations and Study Status
10 March 8, 2022 Contacts/Locations and Study Status
11 May 2, 2022 Contacts/Locations and Study Status
12 June 13, 2022 Study Status
13 August 6, 2022 Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status and Eligibility
14 September 29, 2022 Contacts/Locations and Study Status
15 November 7, 2022 Contacts/Locations and Study Status
16 June 15, 2023 Recruitment Status, Contacts/Locations, Study Status and Study Design
17 February 23, 2024 Recruitment Status, Study Status and Study Design
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Study NCT04563026
Submitted Date:  November 7, 2022 (v15)

Open or close this module Study Identification
Unique Protocol ID: C928-011
Brief Title: A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2022
Overall Status: Recruiting
Study Start: January 22, 2021
Primary Completion: September 2023 [Anticipated]
Study Completion: September 2023 [Anticipated]
First Submitted: September 18, 2020
First Submitted that
Met QC Criteria:
September 18, 2020
First Posted: September 24, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
November 7, 2022
Last Update Posted: November 8, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Durect
Responsible Party: Sponsor
Collaborators: CTI Clinical Trial and Consulting Services
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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).
Detailed Description:
Open or close this module Conditions
Conditions: Alcoholic Hepatitis
Keywords: Alcoholic Hepatitis
acute alcoholic liver disease
progressive inflammatory liver injury
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
This is a Phase 2b randomized, double-blind, placebo-controlled, multi-arm, multi-center, parallel design trial.
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: DUR-928 (larsucosterol, 30 mg) Drug: DUR-928 30 mg
IV infusion
Experimental: DUR-928 (larsucosterol, 90 mg) Drug: DUR-928 90 mg
IV infusion
Placebo Comparator: (Placebo) Sterile Water for Injection Drug: Placebo+ Standard of Care (SOC)
IV infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
[ Time Frame: Day 90 ]

Secondary Outcome Measures:
1. Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
[ Time Frame: Day 90 ]

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

3. Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
[ Time Frame: Day 28 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Able to provide written informed consent (either from subject or subject's legally acceptable representative).
  2. Onset of jaundice within prior 8 weeks.
  3. 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.
  4. 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
    • ALT < 400 IU/L
    • AST/ALT > 1.5
  5. Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
  6. Model for End-stage Liver Disease (MELD) score: 21-30.
  7. 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.
  8. Male or female subjects 18 years of age or older.
  9. Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
  10. Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.

Exclusion Criteria:

  1. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
  2. Subjects 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], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
  4. Serum creatinine >2.5 mg/dL.
  5. Subjects undergoing continuous veno-venous hemodialysis (CVVH).
  6. Uncontrolled gastrointestinal bleeding.
  7. A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
  8. Liver biopsy (if carried out) with findings not compatible with AH.
  9. Stage ≥3 hepatic encephalopathy by West Haven criteria.
  10. Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
  11. Other concomitant cause(s) of liver disease.
  12. Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
  13. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
  14. Existing or intended pregnancy or breast feeding.
  15. Participation in another interventional clinical trial within 30 days of Screening.
  16. History of organ transplantation, other than a corneal transplant.
  17. 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.
Open or close this module Contacts/Locations
Central Contact Person: Christina Blevins, BS
Telephone: 408-777-1417
Email: christina.blevins@durect.com
Central Contact Backup: Deborah Scott, MS
Telephone: 408-777-1417
Email: deborah.scott@durect.com
Study Officials: Robert Gordon, MD, FACS
Study Director
CTI Clinical Trial and Consulting Services
Locations: United States, Alabama
University of Alabama at Birmingham (UAB) Hospital
[Recruiting]
Birmingham, Alabama, United States, 35233
United States, Arizona
St. Joseph's Hospital and Medical Center
[Withdrawn]
Phoenix, Arizona, United States, 85013
Mayo Clinic Hospital
[Not yet recruiting]
Phoenix, Arizona, United States, 85054
United States, California
Southern California Research Center
[Recruiting]
Coronado, California, United States, 92118
Keck Hospital of University of Southern California (USC)
[Recruiting]
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
[Recruiting]
Los Angeles, California, United States, 90048
University of California Davis (UC Davis) Medical Center
[Recruiting]
Sacramento, California, United States, 95817
University of California San Francisco (UCSF) Medical Center
[Recruiting]
San Francisco, California, United States, 94143
Stanford University Medical Center
[Recruiting]
Stanford, California, United States, 94305
United States, Connecticut
Yale University School of Medicine
[Recruiting]
New Haven, Connecticut, United States, 06510
United States, District of Columbia
MedStar Health - MedStar Georgetown University Hospital
[Recruiting]
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami Hospital
[Withdrawn]
Miami, Florida, United States, 33136
United States, Georgia
Piedmont Atlanta Hospital
[Recruiting]
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern Memorial Hospital
[Recruiting]
Chicago, Illinois, United States, 60611
Rush University Medical Center
[Recruiting]
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
[Recruiting]
Chicago, Illinois, United States, 60637
Loyola University Medical Center
[Recruiting]
Maywood, Illinois, United States, 60153
United States, Indiana
Richard Roudebush VA Hospital
[Recruiting]
Indianapolis, Indiana, United States, 46202
United States, Kansas
The University of Kansas Hospital
[Recruiting]
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville
[Recruiting]
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Medical Center
[Recruiting]
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Medical Center
[Recruiting]
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital
[Recruiting]
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Tufts Medical Center
[Recruiting]
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
[Recruiting]
Boston, Massachusetts, United States, 02114
Lahey Hospital and Medical Center
[Withdrawn]
Burlington, Massachusetts, United States, 01805
United States, Michigan
Henry Ford Hospital
[Recruiting]
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Medical School
[Recruiting]
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Health System - Saint Luke's Hospital of Kansas City
[Recruiting]
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
[Recruiting]
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center (UNMC)
[Recruiting]
Omaha, Nebraska, United States, 68198
United States, New Jersey
Rutgers-New Jersey Medical School
[Recruiting]
Newark, New Jersey, United States, 07103
United States, New Mexico
University of New Mexico (UNM) Hospital
[Recruiting]
Albuquerque, New Mexico, United States, 87106
United States, New York
Northwell Health - North Shore University Hospital
[Recruiting]
Manhasset, New York, United States, 11030
Mount Sinai Hospital
[Recruiting]
New York, New York, United States, 10029
New York-Presbyterian - Weill Cornell Medical Center
[Recruiting]
New York, New York, United States, 10065
United States, North Carolina
Atrium Health
[Recruiting]
Charlotte, North Carolina, United States, 28204
United States, South Carolina
Medical University of South Carolina (MUSC) Health - University Medical Center
[Recruiting]
Charleston, South Carolina, United States, 29425
United States, Texas
Methodist Dallas Medical Center
[Recruiting]
Dallas, Texas, United States, 75203
Baylor Scott and White Health
[Recruiting]
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center
[Recruiting]
Dallas, Texas, United States, 75390
Doctors Hospital at Renaissance (DHR)
[Recruiting]
Edinburg, Texas, United States, 78539
Baylor College of Medicine Medical Center
[Recruiting]
Houston, Texas, United States, 77030
Houston Methodist Hospital
[Recruiting]
Houston, Texas, United States, 77030
University of Texas Health (UTHealth) Science Center at Houston
[Recruiting]
Houston, Texas, United States, 77030
United States, Utah
Utah Health - The University of Utah Hospital
[Recruiting]
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia (UVA) Health - University Hospital
[Recruiting]
Charlottesville, Virginia, United States, 22908
Bon Secours Liver Institute of Richmond
[Recruiting]
Richmond, Virginia, United States, 23226
United States, Washington
Harborview Medical Center - University of Washington
[Completed]
Seattle, Washington, United States, 98104
Australia, New South Wales
Royal Prince Alfred Hospital
[Recruiting]
Camperdown, New South Wales, Australia, 2050
Nepean Hospital
[Recruiting]
Kingswood, New South Wales, Australia, 2217
Australia, Queensland
Mater Health - Mater Hospital Brisbane
[Recruiting]
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital
[Recruiting]
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
[Recruiting]
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Eastern Health - Box Hill Hospital
[Recruiting]
Box Hill, Victoria, Australia, 3128
Australia, Western Australia
Sir Charles Gairdner Hospital
[Recruiting]
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
[Recruiting]
Perth, Western Australia, Australia, 6000
Austria
Landeskrankenhaus (LKH) - Universitätsklinikum Graz
[Recruiting]
Graz, Austria, 8036
Belgium
Université libre de Bruxelles (ULB) - Hôpital Erasme
[Recruiting]
Brussels, Belgium, 1070
Universitair Ziekenhuis Antwerpen (UZA)
[Recruiting]
Edegem, Belgium, 2650
France
Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz
[Recruiting]
Besançon, France, 25000
Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre
[Recruiting]
Lille, France, 59037
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
[Recruiting]
Lyon, France, 69004
Hôpital St Joseph
[Recruiting]
Marseille, France, 13008
United Kingdom, England
Barts Health NHS Trust - The Royal London Hospital
[Recruiting]
London, England, United Kingdom, E1 1FR
King's College Hospital NHS Foundation Trust
[Recruiting]
London, England, United Kingdom, SE5 9RS
Imperial College Healthcare NHS Trust - St. Mary's Hospital
[Recruiting]
London, England, United Kingdom, W2 1NY
University Hospitals Plymouth NHS Trust - Derriford Hospital
[Recruiting]
Plymouth, England, United Kingdom, PL6 8DH
United Kingdom, Scotland
NHS Tayside - Ninewells Hospital
[Withdrawn]
Dundee, Scotland, United Kingdom, DD1 9SY
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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