Vosoritide for Short Stature in Turner Syndrome

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated June 24, 2024 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Jun 2024); last known: Recruiting
  2. Minor Start date changed from estimate of Mar 2024 to Apr 12, 2024v4
  3. Notable Lead sponsor: Roopa Kanakatti Shankar to Roopa Kanakatti Shankar, MBBS, MSv3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2024 to Mar 2024
    • Eligibility criteria expanded, about 12 words
    • Site details revised
  4. Notable Start date: Sep 2023 to Jul 2024v2
  5. Minor 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.
Turner syndrome (TS) is characterized by a missing whole or part of the second sex chromosome in a phenotypic female, resulting in short stature due to haploinsufficiency of the short-stature homeobox-containing (SHOX) gene. Growth hormone (GH) is an approved therapy for this condition, although not associated with GH deficiency, and benefits are modest. Vosoritide, a C-type natriuretic peptide (CNP) analog, targets chondrocytes within the growth plate leading to increased cell proliferation and hypertrophy. We hypothesize that patients with TS and short stature will respond to vosoritide treatment leading to increased growth velocity. This study will enroll pre-pubertal girls with TS who are either naïve to GH or have had a poor response to GH therapy. All subjects will be treated with vosoritide for 12 months and will be assessed for safety monitoring and improvement in height outcomes. Annualized growth velocity (AGV) on vosoritide will be compared to AGV in the 6-18 months prior to initiation of vosoritide based on historical data available in the medical record. Subjects with a positive response to therapy will be given the option to continue in the extension phase of the study during which they will continue to receive vosoritide until growth cessation.
Trial Details
NCT Number NCT05849389
Lead Sponsor Roopa Kanakatti Shankar, MBBS, MS
Conditions
(from sponsor)
Turner Syndrome, Short Stature
Related terms Dwarfism, Turner Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov