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NCT05018481 · ClinicalTrials.gov registry record · Early Phase 1
HA35 Moderate Alcoholic Hepatitis (AH) Study
A Early Phase 1 study of Alcoholic Hepatitis, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT05018481: Recruiting Early Phase 1 study of Alcoholic Hepatitis, sponsored by The Cleveland Clinic.
NCT05018481 is a Early Phase 1 study of Alcoholic Hepatitis that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 54 participants, below the 291-participant average among 5 other Alcoholic Hepatitis trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05018481, a Early Phase 1 study of Alcoholic Hepatitis, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sodium Hyaluronate
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2027-10-01 |
| Phase | Early Phase 1 |
What NCT05018481 shows while recruiting
NCT05018481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 291-participant average among 5 other Alcoholic Hepatitis trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Alcoholic Hepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05018481 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05018481 about?
NCT05018481 is a clinical study titled "HA35 Moderate Alcoholic Hepatitis (AH) Study". 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 compos...
What is the current status of trial NCT05018481?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 54 participants. The study started on 2022-09-01. Estimated completion is 2027-10-01.
What conditions does trial NCT05018481 study?
This clinical trial studies the following conditions: Alcoholic Hepatitis.
What interventions are being tested in trial NCT05018481?
The interventions under investigation include: Placebo (DRUG), Sodium Hyaluronate (DRUG).
Who is sponsoring clinical trial NCT05018481?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05018481 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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