The purpose of this randomised, double-blind, placebo-controlled, phase II study is to assess the efficacy and safety of orally administered DS102 in adult patients with acute decompensated alcoholic hepatitis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Participants assigned to the open label pilot phase received 1000mg DS102 (BID)for 28 days.
Schiff Center for Liver Diseases (University Hospital Miami)
Miami, Florida, United States
Cleveland Clinic Florida
Miami, Florida, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
To evaluate the safety of orally administered DS102 in the treatment of adult patients with severe acute decompensated AH.
Time frame: Up to 28 days.
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients With Alcoholic Hepatitis
Descriptive Statistics for Plasma Total 15(S)-HEPE and Unesterified 15(S)-HEPE Pharmacokinetic Results for 1000 mg BD DS102 Administered Orally Twice-daily to Patients with Alcoholic Hepatitis.
Time frame: Up to 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston, Massachusetts, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bon Secours Liver Institute of Richmond and Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
Batumi Referral Hospital
Batumi, Georgia
Saint Nikolozi Surgery Center
Kutaisi, Georgia