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NCT05849389 · ClinicalTrials.gov registry record · Phase 2
Vosoritide for Short Stature in Turner Syndrome
A Phase 2 study of Turner Syndrome and Short Stature, sponsored by Roopa Kanakatti Shankar, MBBS, MS.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05849389: Recruiting Phase 2 study of Turner Syndrome and Short Stature, sponsored by Roopa Kanakatti Shankar, MBBS, MS.
NCT05849389 is a Phase 2 study of Turner Syndrome and Short Stature that is actively recruiting participants, run by Roopa Kanakatti Shankar, MBBS, MS. The registered enrollment target is 20 participants, below the 518-participant average among 14 other Turner Syndrome trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849389, a Phase 2 study of Turner Syndrome and Short Stature, is actively recruiting participants, sponsored by Roopa Kanakatti Shankar, MBBS, MS.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Number of treatment-emergent adverse events or serious adverse events per study participant
Conditions Studied
Interventions
- DRUG Vosoritide
Study Locations (1)
District of Columbia
- Children's National Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-12 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT05849389 shows while recruiting
NCT05849389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 14 other Turner Syndrome trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Turner Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Vosoritide is the first listed.
NCT05849389 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05849389 about?
NCT05849389 is a clinical study titled "Vosoritide for Short Stature in Turner Syndrome". 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...
What is the current status of trial NCT05849389?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-04-12. Estimated completion is 2026-09.
What conditions does trial NCT05849389 study?
This clinical trial studies the following conditions: Turner Syndrome, Short Stature.
What interventions are being tested in trial NCT05849389?
The interventions under investigation include: Vosoritide (DRUG).
Who is sponsoring clinical trial NCT05849389?
This trial is sponsored by Roopa Kanakatti Shankar, MBBS, MS, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05849389 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05849389's enrollment target sits among peer trials
20 14th of 14 the lowest of 14 other Turner Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Turner Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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