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Experimental Medication

DUR-928 30 mg for Alcoholic Hepatitis (AHFIRM Trial)

Phase 2
Waitlist Available
Research Sponsored by Durect
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90
Awards & highlights

Summary

This trial is testing DUR-928, a new medication, in people with Alcoholic Hepatitis to see if it can help their liver heal and function better.

Eligible Conditions
  • Alcoholic Hepatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Secondary outcome measures
Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.

Side effects data

From 2019 Phase 2 trial • 19 Patients • NCT03432260
25%
Pruritus generalised
25%
Renal pain
25%
Anemia
25%
Ascites
25%
Nausea
25%
Hyperkalaemia
25%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Moderate AH DUR-928 30 mg
Moderate AH DUR-928 90 mg
Severe AH DUR-928 30 mg
Severe AH DUR-928 90 mg
Severe AH DUR-928 150 mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: DUR-928 (larsucosterol, 90 mg)Experimental Treatment1 Intervention
Group II: DUR-928 (larsucosterol, 30 mg)Experimental Treatment1 Intervention
Group III: (Placebo) Sterile Water for InjectionPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DUR-928 90 mg
2021
Completed Phase 2
~330
DUR-928 30 mg
2021
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

DurectLead Sponsor
16 Previous Clinical Trials
1,812 Total Patients Enrolled
CTI Clinical Trial and Consulting ServicesOTHER
34 Previous Clinical Trials
3,428 Total Patients Enrolled
Robert Gordon, MD, FACSStudy DirectorCTI Clinical Trial and Consulting Services
~67 spots leftby Sep 2025
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