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 range

21 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
. 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

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

Lille Model for Alcoholic Hepatitis Score

Timeframe: Day 7

Model for End Stage Liver Disease (MELD) Score

Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28

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

Trial details

NCT IDNCT03432260

SponsorDurect

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-09

Results submitted2022-09-29

View on ClinicalTrials.gov More Alcoholic Hepatitis trials

Who can participate

Age range

21 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
. 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

What they're measuring

Lille Model for Alcoholic Hepatitis Score

Timeframe: Day 7

Model for End Stage Liver Disease (MELD) Score

Timeframe: Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28

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