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A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment (AHFIRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04563026
Recruitment Status : Active, not recruiting
First Posted : September 24, 2020
Last Update Posted : June 18, 2023
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Durect

Study Description
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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).

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Drug: DUR-928 30 mg Drug: DUR-928 90 mg Drug: Placebo+ Standard of Care (SOC) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase 2b randomized, double-blind, placebo-controlled, multi-arm, multi-center, parallel design trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563026


Locations
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Sponsors and Collaborators
Durect
CTI Clinical Trial and Consulting Services
Investigators
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Study Director: Robert Gordon, MD, FACS CTI Clinical Trial and Consulting Services
More Information
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Responsible Party: Durect
ClinicalTrials.gov Identifier: NCT04563026    
Other Study ID Numbers: C928-011
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Durect:
Alcoholic Hepatitis
acute alcoholic liver disease
progressive inflammatory liver injury
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders