HA35 Study for Moderate Alcoholic Hepatitis
This study is looking into how Sodium Hyaluronate (HA35) affects people with moderate alcoholic hepatitis. Alcoholic hepatitis is a serious liver condition caused by heavy alcohol use. You might be eligible if you are between 21 and 65 years old, have a specific diagnosis of alcoholic hepatitis, and meet certain lab test results, including a MELD score (a measure of liver disease severity) less than 21. The study aims to see if Sodium Hyaluronate can help improve skeletal muscle mass over 90 days. Participants will receive either Sodium Hyaluronate or a placebo (an inactive capsule) for 90 days. The study's current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 54 participants. Participants will be randomly assigned to receive either Sodium Hyaluronate or a placebo.
- What's involved
- You would take a capsule daily for 90 days, attend two in-person visits (at the start and end of the 90 days), and have two phone visits. In-person visits include physical exams, blood tests, body composition measurements, muscle strength tests, questionnaires, urine and stool collections, a sugar cocktail, and a muscle biopsy. You'll also return for a 24-hour urine collection drop-off.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes from baseline to 90 days, indicating follow-up during this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
HA35 Moderate Alcoholic Hepatitis (AH) Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Compare percent change of skeletal muscle massBaseline to 90 days