Phase 2b Trial of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis, AHFIRM
DURECT is currently conducting a Phase 2b study (AHFIRM) in subjects with Alcohol-associated Hepatitis to evaluate saFety and effIcacy of larsucosterol (DUR-928) treatMent and potential life-saving capacity in patients with severe alcohol-associated hepatitis (AH). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center study.
This trial is currently recruiting patients with severe AH whose Maddrey’s DF score is greater than 32 and MELD scores 21-30.
The study will be comprised of three arms of approximately 100 patients each: (1) larsucosterol (30 mg); (2) larsucosterol (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of larsucosterol or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be the 90-day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores), and time in the intensive care unit.
DURECT is targeting 40-50 clinical trial sites in the United States, Europe and Australia.
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