RECRUITING

HA35 Moderate Alcoholic Hepatitis (AH) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanism of HA35 in Patients with Alcoholic Liver Disease

Quick Facts

Study Start:2022-09-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05018481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * MELD \<21
  3. * Serum total bilirubin \>3 mg/dL
  4. * AST \>50 IU/I; AST:ALT ratio \>1.5; Both AST and ALT \<400 IU/I
  1. * Pregnant or breastfeeding women
  2. * Patients with gastrointestinal bleeding within 2 weeks
  3. * Active infection (positive blood or ascitic fluid culture)
  4. * Overt encephalopathy
  5. * Renal failure and/or on dialysis
  6. * Medications that alter muscle protein metabolism
  7. * Myopathies
  8. * Other end-stage organ diseases
  9. * Malignancy
  10. * Solid organ or hematopoietic transplantation
  11. * Active alcohol withdrawal or ongoing participation in a Clinical Institute Withdrawal Assessment (CIWA) protocol
  12. * History of recent upper gastrointestinal resection within past 6 months
  13. * Acute or chronic liver disease due to other active causes, in addition to alcoholic liver disease
  14. * Inability to provide consent
  15. * Creatinine \>2mg/dL
  16. * Platelets \<60,000k/ul
  17. * PT/INR \>1.7
  18. * Presence of pedal edema
  19. * Use of anti-platelet/anticoagulation drugs or medications that interfere with blood clotting

Contacts and Locations

Study Contact

Srinivasan Dasarathy, MD
CONTACT
216-318-7010
dasaras@ccf.org
Annette Bellar
CONTACT
bellara@ccf.org

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Alcoholic Hepatitis