Vesiculogenesis in Children With GH Deficiency (VESCIGHTP)
Condition(s) studied
Investigational drug(s) / intervention(s)
rhGH: Hormone replacement therapy with rhGH at a dose of 0.025-0.035 mg/kg of body weight per day (or 0.7-1.0 mg/m2 of body surface area per day).
Study summary
The primary objective of the study is to evaluate the size and derivational profile of the extracellular vescicles (EV) generated in children with GH deficiency, undergoing hormone replacement therapy with rhGH. Secondary objectives is to correlate vesiculogenesis with auxometric and biochemical parameters used in clinical-endocrine practice in the evaluation of short stature.
The results of the study will provide useful information to more rationally set up the clinical and biochemical follow-up of hormone replacement therapy with rhGH, as well as to understand the molecular and cellular mechanisms underlying the multi-systemic action of GH, the most important anabolic hormone of the human organism.
Eligibility
Primary outcome measure(s)
- Size of extracellular vesicles — Baseline and after 6 months
Change in size of extracellular vesicles after rhGH treatment - Derivational profile of extracellular vesicles — Baseline and after 6 months
Change in derivational profile of extracellular vesicles after rhGH treatment
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Istituto Auxologico Italiano IRCCS | Milan | Italy |
More Istituto Auxologico Italiano trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05759624 on ClinicalTrials.gov ↗ ← All trials in Italy