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New treatment option for Idiopathic Short Stature
Official title A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature
ClinicalTrials.gov ID: NCT06382155
What this study is testing
What is Vosoritide Injection?
Vosoritide Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for idiopathic short stature.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 11
You may be able to join if
- Height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated...
- If participant is ≥ 5 years at Screening,must be Tanner Stage I to be eligible for enrollment and randomization3. Historic stimulation test result...
- Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome...
- Previous treatment with a growth promoting agent
The study team makes the final eligibility decision.
Where it's taking place
- California City, California, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Sacramento, California, United States
- Torrance, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Pensacola, Florida, United States
- Columbus, Georgia, United States
- Boise, Idaho, United States
- Idaho Falls, Idaho, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Lafayette, Louisiana, United States
- New Orleans, Louisiana, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include California City, California, United States; Los Angeles, California, United States; Oakland, California, United States; Sacramento, California, United States; Torrance, California, United States; Washington D.C., District of Columbia, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.