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

DURECT Corporation0 sites300 target enrollmentJune 24, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 24, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 alcohol for 6 months or longer, with \< 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long\-term alcohol use and onset of jaundice will be made by the site investigator.
•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
•NOTE: Labs values on the day of randomization must include serum total bilirubin \> 3\.0 mg/dL and AST and ALT \< 400 IU/L in addition to the MDF and MELD values in inclusion 5 and 6 below.
•5\. Maddrey discriminant function (MDF) \= 32 assuming a control prothrombin time of 12 seconds NOTE: If a local laboratory’s control time differs from 12 seconds then the local laboratory’s control time should be used.

•1\. Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening. NOTE: Inhaled, topical, or local corticosteroid injections are permitted
•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).
•a. Subjects who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
•b. Patients with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.
•c. Patients with fungal infection of any kind cannot be considered for this trial.
•4\. Serum creatinine \>2\.5 mg/dL
•5\. Criterion removed as part of Protocol Amendment 2, but placeholder kept to maintain consistency in subsequent criteria numbering
•6\. Subjects undergoing continuous veno\-venous hemodialysis (CVVH)
•7\. Uncontrolled gastrointestinal bleeding