DUR-928 in Alcoholic Hepatitis    

Summary

The purpose of this study is to examine an investigational drug called DUR-928 as a possible treatment for alcoholic hepatitis (AH). The MELD score (based on blood test results) is a measurement of how serious liver disease is at a point in time. To be part of this study, an individual’s MELD score must be between 21- 30.

Researchers hope that the use of DUR-928 will lead to improving MELD scores, other liver blood tests, and symptoms of AH. Participants will be randomly assigned to 1 of 3 study groups. Group A will receive 30mg of DUR 928; Group B will receive 90mg of DUR-928, and Group C will receive placebo.

 

 


Inclusion Criteria

  • Able to provide written informed consent (either from subject or subject's legally acceptable representative).
  • Onset of jaundice within prior 8 weeks.
  • Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Randomized, Double-blind, Placebo-controlled, Phase 2b study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Alcoholic Hepatitis

Details
Disease Type/Condition

Other

Principal Investigator

Kuo, Alexander

Co-Investigators

Ju Dong Yang, Juvelyn Palomique, Shi-Hui Pan, Walid Ayoub

Age Group

Adult

Phase

II

IRB Number

STUDY00001360

ClinicalTrials.gov ID

NCT04563026

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Kuo, Alexander

Age Group

Adult

Phase

II

IRB Number

DUR-C928-011

ClinicalTrials.gov ID

NCT04563026

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?