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A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature
EU CTIS ID: 2024-520137-74-00
What this study is testing
Dose-Finding Phase: To evaluate the effect of 3 vosoritide doses versus placebo on AGV after 6 months of treatment Long-Term Phase: To evaluate the effect of the therapeutic dose of vosoritide versus hGH on height and height Z-score after long-term treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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 using the Centers for Disease Control and Prevention (CDC) growth charts
- 2. If a participant is ≥ 5 years of age at Screening, he or she must be assessed as Tanner Stage I to be eligible for enrollment and randomization.
- 3. Participants must be ≥ 3 years old, and < 10 years old (female) or < 11 years old (males) at the time of signing the informed consent form (ICF).
You likely can't join if
- 1. Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene analysis, or Rasopathy (including Noonan syndrome)
- 2. Previous treatment with a growth promoting agent
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Republic of
- United States
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, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Republic of; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.