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Growth Hormone in a Patient With a Dominant-Negative GHR Mutation

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Jul 2, 2025 Secondary endpoints revised (2)v7 Show 1 more changeShow less
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Secondary endpoints: details revised at 1 of 2 entriesv6
  3. Secondary endpoints revised (2)v5 See this version in full on ClinicalTrials.gov ↗
  4. Secondary endpoints revised (2) Primary endpoint revisedv4 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Enrolling by Invitation to Active, Not Recruiting Completion date: Sep 1, 2023 to Sep 1, 2028v3 Show 1 more changeShow less
    • Completion date: Sep 1, 2023 to Sep 1, 2028
  6. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date changed from estimate of Jul 1, 2022 to Aug 26, 2022 · Secondary endpoints revised (2)v2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2022 to Aug 26, 2022
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective interventional study designed for a single patient with a dominant-negative mutation in the growth hormone receptor gene (GHR) which results in increased levels of growth hormone binding protein (GHBP). The patient will receive escalating doses of growth hormone titrated to achieve an insulin like growth factor-1 level above the mean and then growth response to therapy will be monitored.
Trial Details
NCT Number NCT05382637
Lead Sponsor Children's National Research Institute
Conditions Growth Disorders
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov