HA35 Moderate Alcoholic Hepatitis (AH) Study

Launched by THE CLEVELAND CLINIC · Aug 18, 2021

Keywords

ClinConnect Summary

The HA35 Moderate Alcoholic Hepatitis Study is a clinical trial aimed at exploring new treatments for people with alcoholic hepatitis, a serious liver condition caused by heavy drinking. The trial is looking for participants who have been diagnosed with this condition and meet specific criteria, such as having a certain level of liver function and a history of alcohol use. Eligible participants can be men or women aged 18 to 75 who consume alcohol regularly.

If you decide to join the study, you will take either a treatment capsule or a placebo (a capsule with no active medicine) for 90 days. You’ll attend two in-person visits for physical exams, lab tests, and strength assessments, and you’ll answer questions about your health. You’ll also be asked to collect urine samples for 24 hours. There will be two phone check-ins at 30 and 60 days to discuss your experience and how well you’ve followed the treatment plan. This study helps researchers understand how to better treat alcoholic hepatitis, so your participation could contribute to important advancements in care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of alcoholic hepatitis defined as:
• • Regular consumption of alcohol with an intake of \>60 g daily or \>420 g weekly on average for men and \>40 g daily or \>280 g weekly on average for women for 6 months or more
• • AND
• • MELD \<21
• • Serum total bilirubin \>3 mg/dL
• • AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I
• • OR Histologic evidence of AH.
• Exclusion Criteria:
• • Pregnant or breastfeeding women
• • Patients with gastrointestinal bleeding within 2 weeks
• • Active infection (positive blood or ascitic fluid culture)
• • Overt encephalopathy
• • Renal failure and/or on dialysis
• • Medications that alter muscle protein metabolism
• • Myopathies
• • Other end-stage organ diseases
• • Malignancy
• • Solid organ or hematopoietic transplantation
• • Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol
• • History of recent upper gastrointestinal resection within past 6 months
• • Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease
• • Inability to provide consent
• • Creatinine \>2mg/dL
• • Platelets \<60,000k/ul
• • PT/INR \>1.7
• • Presence of pedal edema
• • Use of anti-platelet/anticoagulation drugs or medications that interfere with blood clotting