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 range
21 Years – 67 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).
. 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
. 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.
Biomarkers of liver cell death: Cytokeratin 18 (CK18)
Timeframe: 33 days.
9
Biomarkers of Inflammation (Interleukins): Interleukin 6 and Interleukin 8