CompletedPhase 2

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

United States307 participantsStarted 2021-01-22

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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:
✓. Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
✓. Model for End-stage Liver Disease (MELD) score: 21-30.
✓. 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.
✓. Male or female subjects 18 years of age or older.

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.

What they're measuring

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

Timeframe: Day 90

Trial details

NCT IDNCT04563026

SponsorDurect

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-06

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