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New treatment option for Alcoholic Hepatitis
Official title HA35 Moderate Alcoholic Hepatitis (AH) Study
ClinicalTrials.gov ID: NCT05018481
What this study is testing
What is Sodium Hyaluronate?
Sodium Hyaluronate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for alcoholic hepatitis.
Also referred to as HA35.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Eligible participants will be asked to take a placebo/treatment capsule for 90 days and participate in two in-person study visits, one at the start of the 90 days and the second at the completion of study supplement administration. Both visits will include a physical exam, clinical labs, body composition measurements, muscle strength tests, questionnaires, and urine and stool collections.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.