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Experimental Medication

DUR-928 30 mg for Alcoholic Hepatitis (AHFIRM Trial)

Q: In which geographic locations are the trials of this research taking place?

<p>Stanford University Medical Center in Stanford, <a href="https://www.withpower.com/clinical-trials/california">California</a>, Henry Ford Hospital in Detroit, <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a> and the University of <a href="https://www.withpower.com/clinical-trials/nebraska">Nebraska</a> Medical Centre (UNMC) in Omaha are just a few sites which are participating in this medical trial. Additionally, 88 more locations across the United States are also involved.</p>

Phase 2

Waitlist Available

Research Sponsored by Durect

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90

Awards & highlights

AHFIRM Trial 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

AHFIRM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in 90-day mortality or liver transplant between IV DUR-928, 30 mg or 90 mg, and placebo.

Secondary outcome measures

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.

Difference in 90-day mortality between IV DUR-928, 30 mg or 90 mg, and placebo.

Side effects data

From 2019 Phase 2 trial • 19 Patients • NCT03432260

25%

Renal pain

25%

Pruritus generalised

25%

Anemia

25%

Ascites

25%

Nausea

25%

Hyperkalaemia

25%

Blood alkaline phosphatase increased

100%

80%

60%

40%

20%

Study treatment Arm

Moderate AH DUR-928 30 mg

Moderate AH DUR-928 90 mg

Severe AH DUR-928 30 mg

Severe AH DUR-928 90 mg

Severe AH DUR-928 150 mg

AHFIRM Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: DUR-928 (larsucosterol, 90 mg)Experimental Treatment1 Intervention

Group II: DUR-928 (larsucosterol, 30 mg)Experimental Treatment1 Intervention

Group III: (Placebo) Sterile Water for InjectionPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DUR-928 30 mg

2021

Completed Phase 2

~330

DUR-928 90 mg

2021

Completed Phase 2

~330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

DurectLead Sponsor

16 Previous Clinical Trials

1,812 Total Patients Enrolled

CTI Clinical Trial and Consulting ServicesOTHER

34 Previous Clinical Trials

3,428 Total Patients Enrolled

Robert Gordon, MD, FACSStudy DirectorCTI Clinical Trial and Consulting Services

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which geographic locations are the trials of this research taking place?

"Stanford University Medical Center in Stanford, California, Henry Ford Hospital in Detroit, Michigan and the University of Nebraska Medical Centre (UNMC) in Omaha are just a few sites which are participating in this medical trial. Additionally, 88 more locations across the United States are also involved."

Answered by AI

Are recruitment efforts still underway for this clinical experiment?

"Affirmative. According to the clinicaltrials.gov website, this medical trial is still recruiting potential candidates and was initially published on January 22nd 2021; its most current revision occurred on November 7th 2022. The experiment seeks 300 participants from 88 distinct sites across America."

Answered by AI

Has the FDA sanctioned a 30 milligram dosage of DUR-928?

"Drawing from the available evidence, Power has assigned a safety score of 2 to DUR-928 30 mg as this is still in Phase 2. This means while there are some data suggesting its safe use, no confirmation on efficacy exists yet."

Answered by AI

How many individuals have volunteered to partake in this clinical trial?

"This study demands 300 applicants that meet the pre-established requirements. These individuals can sign up at a variety of locations like Stanford University Medical Center and Henry Ford Hospital, located in California and Michigan respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

2021. "A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04563026.