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DUR-928 30 mg for Alcoholic Hepatitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alcoholic HepatitisDUR-928 30 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new medication for alcoholic hepatitis, a serious liver disease. The trial will compare the new medication to a placebo to see if it is safe and effective.

Eligible Conditions
  • Alcoholic Hepatitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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HA35 Treatment Group
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HA35 Treatment Group
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OA-235i (4-30 mg)

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Day 1 to Day 90

Day 28
ICU days at Day 28
Day 90
Occurrence of adverse events or laboratory abnormalities
Day 28
28-day mortality between the treatment groups
Difference in 28-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Difference in 28-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.
MELD score at Day 28 after the initiation of study drug treatment between the treatment groups
Day 7
Lille score at Day 7 after the initiation of study drug treatment between the treatment groups
Day 90
90-day mortality between active group/s and placebo (SOC) group
Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.
Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
HA35 Treatment Group
1
HA35 Treatment Group
1
OA-235i (4-30 mg)

Side Effects for

Moderate AH DUR-928 90 mg
33%Food poisoning
33%Cough
33%Rhinorrhoea
33%Sinus congestion
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03432260) in the Moderate AH DUR-928 90 mg ARM group. Side effects include: Food poisoning with 33%, Cough with 33%, Rhinorrhoea with 33%, Sinus congestion with 33%.

Trial Design

5 Treatment Groups

DUR-928 (30 mg)
1 of 5
DUR-928 (90 mg)
1 of 5
DUR-928 (larsucosterol, 30 mg)
1 of 5
DUR-928 (larsucosterol, 90 mg)
1 of 5
(Placebo) Sterile Water for Injection
1 of 5

Experimental Treatment

Non-Treatment Group

300 Total Participants · 5 Treatment Groups

Primary Treatment: DUR-928 30 mg · Has Placebo Group · Phase 2

DUR-928 (30 mg)
Drug
Experimental Group · 1 Intervention: DUR-928 30 mg · Intervention Types: Drug
DUR-928 (90 mg)
Drug
Experimental Group · 1 Intervention: DUR-928 90 mg · Intervention Types: Drug
DUR-928 (larsucosterol, 30 mg)
Drug
Experimental Group · 1 Intervention: DUR-928 30 mg · Intervention Types: Drug
DUR-928 (larsucosterol, 90 mg)
Drug
Experimental Group · 1 Intervention: DUR-928 90 mg · Intervention Types: Drug
(Placebo) Sterile Water for Injection
Drug
PlaceboComparator Group · 1 Intervention: Placebo+ Standard of Care (SOC) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DUR-928 30 mg
2018
Completed Phase 2
~20
DUR-928 90 mg
2018
Completed Phase 2
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 90

Who is running the clinical trial?

CTI Clinical Trial and Consulting ServicesOTHER
33 Previous Clinical Trials
3,264 Total Patients Enrolled
DurectLead Sponsor
16 Previous Clinical Trials
1,812 Total Patients Enrolled
Robert Gordon, MD, FACSStudy DirectorCTI Clinical Trial and Consulting Services

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
AST/ALT > 1.5.
You have a MELD score of at least 21-30.
Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator's discretion
You are able to provide written informed consent.\n
You have a prothrombin time of 12 seconds or less.
References

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