ClinicalTrials.gov

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
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
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
Comparison Format:

Scroll up to access the controls

Study NCT04563026
Submitted Date:  June 15, 2023 (v16)

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: Active, not 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:
June 15, 2023
Last Update Posted: June 18, 2023 [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: 301 [Actual]
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
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
Birmingham, Alabama, United States, 35233
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
Southern California Research Center
Coronado, California, United States, 92118
Keck Hospital of University of Southern California (USC)
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California Davis (UC Davis) Medical Center
Sacramento, California, United States, 95817
University of California San Francisco (UCSF) Medical Center
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
MedStar Health - MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Richard Roudebush VA Hospital
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Saint Luke's Health System - Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center (UNMC)
Omaha, Nebraska, United States, 68198
United States, New Jersey
Rutgers-New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New Mexico
University of New Mexico (UNM) Hospital
Albuquerque, New Mexico, United States, 87106
United States, New York
Northwell Health - North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Hospital
New York, New York, United States, 10029
New York-Presbyterian - Weill Cornell Medical Center
New York, New York, United States, 10065
United States, North Carolina
Atrium Health
Charlotte, North Carolina, United States, 28204
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina (MUSC) Health - University Medical Center
Charleston, South Carolina, United States, 29425
United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Baylor Scott and White Health
Dallas, Texas, United States, 75246
University of Texas Southwestern (Clements University Hospital)
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Doctors Hospital at Renaissance (DHR)
Edinburg, Texas, United States, 78539
Baylor College of Medicine Medical Center
Houston, Texas, United States, 77030
Houston Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Utah Health - The University of Utah Hospital
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia (UVA) Health - University Hospital
Charlottesville, Virginia, United States, 22908
Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States, 23226
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
United States, Washington
Harborview Medical Center - University of Washington
Seattle, Washington, United States, 98104
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Nepean Hospital
Kingswood, New South Wales, Australia, 2217
Australia, Queensland
Mater Health - Mater Hospital Brisbane
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Eastern Health - Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Austria
Landeskrankenhaus (LKH) - Universitätsklinikum Graz
Graz, Austria, 8036
Belgium
Université libre de Bruxelles (ULB) - Hôpital Erasme
Brussels, Belgium, 1070
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Belgium, 2650
France
Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz
Besançon, France, 25000
Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre
Lille, France, 59037
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, France, 69004
Hôpital St Joseph
Marseille, France, 13008
United Kingdom
Royal Free London NHS Foundation Trust Hospital
London, United Kingdom, NW3 2QG
United Kingdom, England
Barts Health NHS Trust - The Royal London Hospital
London, England, United Kingdom, E1 1FR
King's College Hospital NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Imperial College Healthcare NHS Trust - St. Mary's Hospital
London, England, United Kingdom, W2 1NY
University Hospitals Plymouth NHS Trust - Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services