Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04219007 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Vosoritide for Selected Genetic Causes of Short Stature

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Oct 15, 2025 to Aug 14, 2025v10
  2. Trial status: Recruiting to Active, Not Recruitingv9 Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 56
    • Primary completion date: Dec 31, 2025 to Oct 15, 2025
    • Study completion date: Jun 1, 2026 to Jun 1, 2035
    • Site details revised
  3. Trial status: Active, Not Recruiting to Recruitingv8 Show 5 more changesShow less
    • Enrollment target: 35 to 60
    • Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study completion date: Jun 1, 2024 to Jun 1, 2026
    • Eligibility criteria expanded, about 7 words
    • Site details revised
  4. Primary completion date: Jan 1, 2023 to Dec 31, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 1, 2023 to Jun 1, 2024
    • Site details revised
    v7
  5. Eligibility criteria expanded, about 287 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date changed from estimate of Jul 15, 2020 to Aug 4, 2020v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  3. Start date: May 1, 2020 to Jul 15, 2020
    • Eligibility criteria expanded, about 144 words
    • Study title expanded, about 2 words
    v3
  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Short stature can be caused by a number of genetic etiologies, many of which directly affect the growth plate. The FGFR3/CNP pathway is central to growth of the chondrocyte. The study team hypothesizes that patients with selected genetic causes of short stature that interact with this pathway will benefit from treatment with vosoritide, a CNP analog, a selective NPR-B agonist which directly targets the growth plate. This study will enroll patients with short stature in selected genetic categories and will follow them for a 6 month observation period to obtain a baseline growth velocity, safety profile and quality of life assessment. Patients will then be treated with vosoritide for 12 months and will be assessed for safety monitoring and improvement in height outcomes.
Trial Details
NCT Number NCT04219007
Lead Sponsor Andrew Dauber
Conditions
(from sponsor)		 Short Stature
Related terms Dwarfism, Hypochondroplasia, Noonan Syndrome
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov