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A Randomized Double‐Blind Placebo‐Controlled Phase 2b Study to Evaluate Safety and Efficacy of DUR‐928 in Subjects with Alcoholic Hepatitis

Clinical Trial Details

This is a randomized, double‐blind, placebo‐controlled study evaluating the safety and efficacy of the study drug DUR‐928 in individuals who have been diagnosed with Alcoholic Hepatitis (AH). The purpose of this study is to see if the investigational/experimental drug DUR‐928 may help in the treatment of AH.

AH occurs because the liver has had a reaction to the alcoholic you have been drinking. The hope is that the study drug DUR‐928 may lead to lowering the MELD score (liver disease measurement), liver blood tests, and then other symptoms of AH may get better.

An investigational/experimental drug is one that is currently being tested and has not been approved by the Food and Drug Administration (FDA) for sale in the United States or by any regulatory authorities in any country in the world. Experimental drugs such as DUR‐928 may be tested in research studies such as this one.

If an individual agrees to participate and meets all the requirements, participants will be randomized to one of the following study groups:

Group A: 30 mg of DUR‐928
Group B: 90 mg of DUR‐928
Group C: Placebo (sterile water)

The placebo (sterile water or capsules) will look like DUS‐928 but will not contain active medicine/ingredients. DUR‐928, methylprednisolone, and placebo will be supplied by Durect Corporation, which is the sponsor of this study.

Participation in this study will last approximately 90 days and includes up to 15 visits (in‐person visits or telephone calls) with the study team.

Participants will be compensated for their time.

Key Eligibility: 
  • Men and women who are 18 years of age and older.
  • Have been diagnosed with Alcoholic Hepatitis (AH).
  • Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Mallory Ianelli, RN, BSN
(646) 962-4040
mai2016@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2008022575

ClinicalTrials.gov:

NCT04563026

Sponsor:

C928-011

Status

Open to Enrollment

Age Group

Adult

Sponsor