A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patien… (NCT03432260) | Clinical Trial Compass
CompletedPhase 2
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
United States19 participantsStarted 2018-04-18
Plain-language summary
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Able to provide written informed consent (either from patient or patient's legally acceptable representative)
✓. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2
✓. Patients with alcoholic hepatitis defined as:
✓. History of heavy alcohol abuse: \> 40 g/day in females or \> 60 g/day in males for a minimum period of 6 months, AND
✓. Consumed alcohol within 12 weeks of entry into the study, AND
✓. Serum bilirubin \> 3 mg/dL AND AST \> ALT, but less than 300 U/L AND
✓. MELD score between 11-30, inclusive
✓. No evidence of active infection as determined by the investigator.
Exclusion criteria
✕. Other or concomitant cause(s) of liver disease as a result of:
✕. Autoimmune liver disease
✕. Wilson disease
✕. Vascular liver disease
✕. Drug induced liver disease
✕. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B
What they're measuring
1
Lille Model for Alcoholic Hepatitis Score
Timeframe: Day 7
2
Model for End Stage Liver Disease (MELD) Score
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28
3
Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline
Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28