DUR-928 in Patients With Alcoholic Hepatitis (NCT03917407) | Clinical Trial Compass
CompletedPhase 2
DUR-928 in Patients With Alcoholic Hepatitis
United States43 participantsStarted 2021-06-01
Plain-language summary
The proposed study is An Open-Label, Dose Escalation Study to Assess the Safety, and Pharmacodynamics (PD) signals of DUR 928 in Patients with AH. DUR-928 will be administered in 100 mL 5% dextrose or 0.9% sodium chloride by slow intravenous infusion over 2 hrs (50mL/h) until entire dose is given at Day 1 and Day 4. If a patient meets the hospital discharge criteria prior to the 2nd dose, the patient will receive only one dose of DUR-928 instead of 2 doses.
Who can participate
Age range21 Years – 67 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. If infection is initially suspected clinically,
Exclusion criteria
✕. Other or concomitant cause(s) of liver disease as a result of:
✕. Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer \> 1:160)
✕. Wilson disease (ceruloplasmin levels \< 10 mcg/L)
✕. Vascular liver disease
✕. Drug induced liver disease
What they're measuring
1
Assessment of Treatment-Emergent Adverse Events
Timeframe: 4.5 years.
2
Pharmacodynamic signals of DUR-928: Model for End-Stage Liver Disease [MELD]
Timeframe: 33 days.
3
Pharmacodynamic signals of DUR-928: Liver Biochemical Biomarker "Alanine Aminotransferase"
Timeframe: 33 days.
4
Pharmacodynamic signals of DUR-928: Liver Biochemical Biomarker "Aspartate Aminotransferase"
Timeframe: 33 days.
5
Pharmacodynamic signals of DUR-928: Liver Biochemical Biomarker "Total Bilirubin"
Timeframe: 33 days.
6
Pharmacodynamic signals of DUR-928: Liver Biochemical Biomarker "Albumin"
Timeframe: 33 days.
7
Quality of life biomarkers: 36-item Short Form Survey (SF-36).
Timeframe: 33 days.
8
Biomarkers of liver cell death: Cytokeratin 18 (CK18)
. Surface antigen positive hepatitis B (HBsAg+). Note: patients with isolated core antibody (HBcAb) are not excluded.
✕. Acute hepatitis A
✕. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. Note: patients with stable chronic Hep C Virus (HCV) or successfully treated HCV are not excluded.
9
Biomarkers of Inflammation (Interleukins): Interleukin 6 and Interleukin 8