A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis

Durect68 sites in 2 countries307 target enrollmentJanuary 22, 2021

ConditionsAlcoholic Hepatitis

InterventionsDUR-928 30 mg DUR-928 90 mg Placebo+ Standard of Care (SOC)

DrugsDUR-928 30 mg DUR-928 90 mg Placebo+ Standard of Care (SOC)

Overview

Phase: Phase 2
Intervention: DUR-928 30 mg
Conditions: Alcoholic Hepatitis
Sponsor: Durect
Enrollment: 307
Locations: 68
Primary Endpoint: Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 22, 2021

End Date

September 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Durect

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to provide written informed consent (either from subject or subject's legally acceptable representative).
•Onset of jaundice within prior 8 weeks.
•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.
•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
•Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
•Model for End-stage Liver Disease (MELD) score: 21-

Exclusion Criteria

•Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
•Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
•Active infection (such as spontaneous bacterial peritonitis \[SBP\], urinary tract infection \[UTI\], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
•Serum creatinine \>2.5 mg/dL.
•Subjects undergoing continuous veno-venous hemodialysis (CVVH).
•Uncontrolled gastrointestinal bleeding.
•A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
•Liver biopsy (if carried out) with findings not compatible with AH.
•Stage ≥3 hepatic encephalopathy by West Haven criteria.
•Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.

Arms & Interventions

DUR-928 (larsucosterol, 30 mg)

Intervention: DUR-928 30 mg

DUR-928 (larsucosterol, 90 mg)

Intervention: DUR-928 90 mg

(Placebo) Sterile Water for Injection

Intervention: Placebo+ Standard of Care (SOC)

Outcomes

Primary Outcomes

Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.

Time Frame: Day 90

Secondary Outcomes

Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.(Day 90)
Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.(Day 28)
Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.(Day 28)