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Epigenetic Regulator

Arm1: DUR-928 treatment for moderate alcoholic hepatitis for Alcoholic Hepatitis (DUR-928/AH Trial)

Phase 2

Waitlist Available

Led By Craig J McClain, M.D.

Research Sponsored by Craig James McClain

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 4.5 years.

Awards & highlights

DUR-928/AH Trial Summary

This trial is to study the safety and effects of the drug DUR-928 in patients with AH (acute hepatitis). The drug will be given intravenously in two doses, four days apart. The trial will study the effects of the drug on the liver and how the body processes it.

Eligible Conditions

Alcoholic Hepatitis

DUR-928/AH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4.5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of Treatment-Emergent Adverse Events

Biomarkers of Inflammation (Interleukins): Interleukin 6 and Interleukin 8

Biomarkers of Inflammation: C-reactive Protein

+7 more

DUR-928/AH Trial Design

2Treatment groups

Active Control

Group I: Arm1: DUR-928 treatment for moderate alcoholic hepatitisActive Control1 Intervention

Enrolled alcoholic hepatitis patients would have MELD of 11-20; and have met inclusion and exclusion criteria. DUR-928 as a novel study treatment would be administered in patients with moderate alcoholic hepatitis (AH) as determined by the absence of suspected unexpected serious adverse reaction (SUSAR).

Group II: Arm 2: DUR-928 treatment for severe alcoholic hepatitis.Active Control1 Intervention

Enrolled alcoholic hepatitis patients would have MELD of 21-30; and have met inclusion and exclusion criteria. DUR-928 as a novel study treatment would be administered in patients with severe alcoholic hepatitis (AH) as determined by the absence of suspected unexpected serious adverse reaction (SUSAR).

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Who is running the clinical trial?

Craig James McClainLead Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

799 Previous Clinical Trials

1,362,468 Total Patients Enrolled

Craig J McClain, M.D.Principal InvestigatorDepartment of Medicine, University of Louisville

Media Library

DUR-928 (Epigenetic Regulator) Clinical Trial Eligibility Overview. Trial Name: NCT03917407 — Phase 2

Alcoholic Hepatitis Research Study Groups: Arm1: DUR-928 treatment for moderate alcoholic hepatitis, Arm 2: DUR-928 treatment for severe alcoholic hepatitis.

Alcoholic Hepatitis Clinical Trial 2023: DUR-928 Highlights & Side Effects. Trial Name: NCT03917407 — Phase 2

DUR-928 (Epigenetic Regulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03917407 — Phase 2

Frequently Asked Questions

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

Are there any harmful side effects to taking Arm1: DUR-928 for moderate alcoholic hepatitis?

"Arm1: DUR-928 has been studied in Phase 2 trials, so while there is some evidence indicating it is safe, none of the data collected suggests that it is an effective treatment for moderate alcoholic hepatitis."

Answered by AI

Are participants being recruited for this experiment currently?

"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov from November 8th, 2022. The trial was first posted June 1st, 2021 and is looking for a total of 36 participants at 1 site."

Answered by AI

How can I become a participant in this clinical trial?

"This study is investigating the treatment of hepatitis A in patients aged 21-67. To qualify, potential participants must only suffer from hepatitis A. The recruitment goal for this clinical trial is 36 individuals."

Answered by AI