Back to resultsHA35 Moderate Alcoholic Hepatitis (AH) Study
Primary Purpose
Alcoholic Hepatitis
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sodium Hyaluronate
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alcoholic Hepatitis
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
Sites / Locations
- Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
HA35 Placebo Group
HA35 Treatment Group
Arm Description
24 study participants will receive the standard of care treatment for AH and a 90-day supply of a placebo to take once a day with breakfast.
24 study participants will receive the standard of care treatment for AH and a 90-day supply of a HA35 to take once a day with breakfast.
Outcomes
Primary Outcome Measures
Compare percent change of skeletal muscle mass
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05018481
Brief Title
HA35 Moderate Alcoholic Hepatitis (AH) Study
Official Title
Mechanism of HA35 in Patients With Alcoholic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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. Additionally, a sugar cocktail will be consumed to measure gut permeability and a muscle biopsy will be collected. The day after the visits, you will need to return to drop off the 24-hour urine collection.
Two phone visits will be performed in between the in-person visits at day 30 and 60 where you will be asked a series of questionnaires as well as asked about study supplement compliance.
Detailed Description
Written informed consent will be obtained during the baseline visit (day 1). Patients will given a physical exam and a blood test will be obtained if not in their medical chart. The subjects who meet the criteria after the screening visit will have the following procedures: A. Body composition will be quantified by whole-body dual energy X-ray absorptiometry (DEXA), Bioelectric Impedance Analysis (BIA), chair stands, 3 position balance and hand grip strength by dynamometry. B. Muscle biopsy from the lateral portion of vastus lateralis, about 20 cm above knee, C. Questionnaires, D. Blood collection, E. Collection of stool samples, F. Sugar cocktail administration, and G. Urine collection (24 hour)
After baseline measures have been completed, patients will be randomized in a 1:1 ratio to either standard of care (SOC) + HA35 or SOC + placebo (140 mg/d) for a total of 3 months post enrollment.
The subjects will be recalled after 3 months. The visit and the procedures conducted on day 90 will be similar to the baseline study visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HA35 Placebo Group
Arm Type
Placebo Comparator
Arm Description
24 study participants will receive the standard of care treatment for AH and a 90-day supply of a placebo to take once a day with breakfast.
Arm Title
HA35 Treatment Group
Arm Type
Active Comparator
Arm Description
24 study participants will receive the standard of care treatment for AH and a 90-day supply of a HA35 to take once a day with breakfast.
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
HA35
Intervention Description
Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A placebo will be given in capsule form to study participants
Primary Outcome Measure Information:
Title
Compare percent change of skeletal muscle mass
Time Frame
Baseline to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Srinivasan Dasarathy, MD
Phone
216-318-7010
Email
dasaras@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Annette Bellar
Email
bellara@ccf.org
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Bellar
12. IPD Sharing Statement
Learn more about this trial
HA35 Moderate Alcoholic Hepatitis (AH) Study
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