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HA35 Moderate Alcoholic Hepatitis (AH) Study

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 1, 2026 → Oct 1, 2028
See other at-risk trials from The Cleveland Clinic

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 1, 2026 to Oct 1, 2028
    • Study completion pushed from Oct 1, 2027 to Oct 1, 2028
    • Eligibility criteria expanded, about 15 words
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Oct 1, 2025 to Oct 1, 2026
    • Study completion date: Oct 1, 2026 to Oct 1, 2027
    v11
  3. 2 versions Re-verified since Oct 10, 2024, no change to tracked fieldsv9-v10
  4. Primary completion date: Oct 1, 2024 to Oct 1, 2025
    • Study completion date: Oct 1, 2025 to Oct 1, 2026
    v8
  5. Primary completion date: Oct 1, 2023 to Oct 1, 2024
    • Study completion date: Oct 1, 2024 to Oct 1, 2025
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v6
  2. Start date: Mar 1, 2022 to Sep 1, 2022v5
  3. Start date: Dec 1, 2021 to Mar 1, 2022v4
  4. Start date: Oct 1, 2021 to Dec 1, 2021v3
  5. Eligibility criteria expanded, about 22 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05018481
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Alcoholic Hepatitis
Related terms Hepatitis, Alcoholic
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov