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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years.
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 moreAwards & 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).
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Who is running the clinical trial?
Craig James McClainLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,727 Total Patients Enrolled
Vatsalya Vatsalya, M.D.Study DirectorDepartment of Medicine, University of Louisville
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other reasons for liver disease besides the one being studied.You have a co-infection with the human immunodeficiency virus (HIV).You have had alcohol within the past 12 weeks before joining the study.You have a severe brain condition called encephalopathy, as determined by a specific set of criteria.You have a history of drinking a lot of alcohol every day for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm1: DUR-928 treatment for moderate alcoholic hepatitis
- Group 2: Arm 2: DUR-928 treatment for severe alcoholic hepatitis.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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