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PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212)

Study acronym: OraGrowtH212
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jun 2023 to Apr 2030v9
  2. Re-verified, no change to tracked fieldsv8
  3. Study title expanded, about 1 wordv7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  5. Study completion date: Jul 2023 to Jul 2030v5 Show 4 more changesShow less
    • Eligibility criteria expanded, about 91 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 3 words
    • Study title expanded, about 1 word
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Oct 2022 to Jun 2023v4 Show 6 more changesShow less
    • Study completion date: Nov 2022 to Jul 2023
    • Start date changed from estimate of Jun 2021 to Jul 14, 2021
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 8 words
    • Study title revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  3. Phase: Early Phase 1 to Phase 2
    • Start date: Apr 2021 to Jun 2021
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goals of this single site trial are to study the pharmacokinetics (PK) and pharmacodynamics of LUM-201 and effects of LUM-201 administration on growth hormone release over time in children with idiopathic pediatric growth hormone deficiency (PGHD).
Trial Details
NCT Number NCT04806854
Lead Sponsor Lumos Pharma
Conditions
(from sponsor)		 Growth Hormone Deficiency
Related terms Dwarfism, Pituitary
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov