Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis (NCT03452540) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis
Stopped: Company Decision
United States9 participantsStarted 2018-11-28
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patients aged 18 years and older
✓. Total bilirubin of ≥ 5 mg/dl (85μmol/l)
✓. Patients with definite or probable AH
✓. MELD ≥18 at baseline visit
✓. MDF ≥32 at baseline visit
✓. AST ≥50 U/L
✓. AST':ALT ratio \> 1.5
✓. Female patients, or female partners of male patients, of child bearing potential must use highly effective birth control methods or have a sterilised partner for the duration of the study. Highly effective birth control methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include intrauterine device or sexual abstinence.
Exclusion criteria
✕. Pregnant or lactating females.
✕. Spontaneous liver function improvement defined by decrease of bilirubin level and MDF of \>10% within 5 days of hospital admission
✕. Grade 4 hepatic encephalopathy (West Haven Criteria)
✕. Type 1 hepatorenal syndrome (HRS) or a serum creatinine \>2 x ULN or the requirement for haemodialysis
✕. History of hypersensitivity to any substance in DS102 capsules or placebo capsules.
What they're measuring
1
Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and SUSARs.
Timeframe: Up to 28 days.
2
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