A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 30, 2026 → Oct 30, 2028
See other at-risk trials from EpiDestiny, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Oct 30, 2026 to Oct 30, 2028
    • Study completion pushed from Apr 30, 2027 to Jan 20, 2029
    • Eligibility criteria expanded, about 10 words
  2. Primary completion date: Mar 8, 2024 to Oct 30, 2026
    • Study completion date: Apr 5, 2024 to Apr 30, 2027
    v9
  3. Primary completion date: Feb 5, 2023 to Mar 8, 2024
    • Study completion date: Mar 3, 2023 to Apr 5, 2024
    v8
  4. Primary completion date: Feb 5, 2022 to Feb 5, 2023
    • Study completion date: Mar 3, 2022 to Mar 3, 2023
    v7
  5. Primary completion date: Feb 5, 2021 to Feb 5, 2022
    • Study completion date: Mar 3, 2021 to Mar 3, 2022
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 3, 2020 to Jan 24, 2020
    v5
  2. Start date: Oct 7, 2019 to Feb 3, 2020
    • Primary completion date: Oct 7, 2020 to Feb 5, 2021
    • Study completion date: Dec 10, 2020 to Mar 3, 2021
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Collaborators: 1 to 2v2
  1. Study First Submitted
  • 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.
A randomized control trial in 20 subjects with sickle cell disease comparing oral THU-decitabine to nicotinamide and in combination (THU, decitabine and nicotinamide).
Trial Details
NCT Number NCT04055818
Lead Sponsor EpiDestiny, Inc.
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov