Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06668805 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Vosoritide in Children With Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone Treatment

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Trial sites reduced: 41 → 38 locations
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 34 entries
  2. Trial sites expanded: 36 → 41 locations
    • Eligibility criteria shortened, about 31 words
    v9
  3. Enrollment reduced: 54 → 30 participants
    • Trial sites expanded: 24 → 36 locations
    • Study description shortened, about 10 words
    • Study title shortened, about 9 words
    v8
  4. Enrollment target: 72 to 54v7 Show 7 more changesShow less
    • Study sites: 20 to 24
    • Interventions: Human Growth Hormone (Drug), Vosoritide Injection (Drug) to Vosoritide Injection (Drug)
    • Eligibility criteria shortened, about 58 words
    • Secondary endpoints revised (34)
    • Study description shortened, about 12 words
    • Study arms: 4 to 3
    • Study title expanded, about 3 words
  5. Study sites: 17 to 20v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 13 to 17
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 23 to 34
    v5
  2. Study sites: 10 to 13v4
  3. Study sites: 5 to 10v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Nov 2024 to Nov 22, 2024
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study in children with Noonan syndrome is to evaluate the effect of 3 doses of vosoritide on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.
Trial Details
NCT Number NCT06668805
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Noonan Syndrome
Related terms Bone Diseases, Dwarfism, Musculoskeletal Diseases, Noonan Syndrome
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov