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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
No Placebo-Only Group

Summary

This trial tests DUR-928, a drug given through a drip, in individuals with serious liver issues. It aims to see if the drug is safe and how it impacts liver health.

Eligible Conditions
  • Alcoholic Hepatitis

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Treatment-Emergent Adverse Events
Biomarkers of Inflammation (Interleukins): Interleukin 6 and Interleukin 8
Biomarkers of Inflammation: C-reactive Protein
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Find a Location

Who is running the clinical trial?

Craig James McClainLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
837 Previous Clinical Trials
1,082,991 Total Patients Enrolled
Vatsalya Vatsalya, M.D.Study DirectorDepartment 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
~10 spots leftby Dec 2025