Study 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.
- Alcoholic Hepatitis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
10 Primary · 0 Secondary · Reporting Duration: 4.5 years.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm1: DUR-928 treatment for moderate alcoholic hepatitis
1 of 2
Arm 2: DUR-928 treatment for severe alcoholic hepatitis.
1 of 2
Active Control
36 Total Participants · 2 Treatment Groups
Primary Treatment: Arm1: DUR-928 treatment for moderate alcoholic hepatitis · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 21 - 67 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Thursz, Mark R., Paul Richardson, Michael Allison, Andrew Austin, Megan Bowers, Christopher P. Day, Nichola Downs, et al.. 2015. “Prednisolone or Pentoxifylline for Alcoholic Hepatitis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1412278.
- O'Shea, Robert S., and Arthur J. McCullough. 2005. “Treatment of Alcoholic Hepatitis”. Clinics in Liver Disease. Elsevier BV. doi:10.1016/j.cld.2004.11.004.
- Orman, Eric S, Gemma Odena, and Ramon Bataller. 2013. “Alcoholic Liver Disease: Pathogenesis, Management, and Novel Targets for Therapy”. Journal of Gastroenterology and Hepatology. Wiley. doi:10.1111/jgh.12030.
- Menon, K. V. Narayanan, Gregory J. Gores, and Vijay H. Shah. 2001. “Pathogenesis, Diagnosis, and Treatment of Alcoholic Liver Disease”. Mayo Clinic Proceedings. Elsevier BV. doi:10.4065/76.10.1021.
- Liangpunsakul, Suthat. 2011. “Clinical Characteristics and Mortality of Hospitalized Alcoholic Hepatitis Patients in the United States”. Journal of Clinical Gastroenterology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mcg.0b013e3181fdef1d.
- FDA, Draft guidance for Drug Interaction Studies. February 2012.
- Thursz, Mark R., Paul Richardson, Michael Allison, Andrew Austin, Megan Bowers, Christopher P. Day, Nichola Downs, et al.. 2015. “Prednisolone or Pentoxifylline for Alcoholic Hepatitis”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1412278.
- O'Shea RS, McCullough AJ. Treatment of alcoholic hepatitis. Clin Liver Dis. 2005 Feb;9(1):103-34. doi: 10.1016/j.cld.2004.11.004.
- Orman ES, Odena G, Bataller R. Alcoholic liver disease: pathogenesis, management, and novel targets for therapy. J Gastroenterol Hepatol. 2013 Aug;28 Suppl 1(0 1):77-84. doi: 10.1111/jgh.12030.
- Menon KV, Gores GJ, Shah VH. Pathogenesis, diagnosis, and treatment of alcoholic liver disease. Mayo Clin Proc. 2001 Oct;76(10):1021-9. doi: 10.4065/76.10.1021.
- Craig James McClain 2021. "DUR-928 in Patients With Alcoholic Hepatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03917407.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
How large is the sample size for this clinical experiment?
"That is correct. According to the most recent update, this clinical trial which was first posted on 6/1/2021 is admitting 36 patients from 1 site." - Anonymous Online Contributor
If a patient is not yet 55 years old, are they still eligible for this particular research program?
"To be eligible for this clinical trial, patients must fall within the age range of 21 to 67 years old." - Anonymous Online Contributor