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ACTIVE NOT RECRUITING
NCT05759624

Vesiculogenesis in Children With GH Deficiency (VESCIGHTP)

Sponsor: Istituto Auxologico Italiano

View on ClinicalTrials.gov

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.

Official title: Evaluation of Vesiculogenesis in Children With GH Deficiency Undergoing Hormone Replacement Therapy

Key Details

Gender

All

Age Range

5 Years - 15 Years

Study Type

OBSERVATIONAL

Enrollment

10

Start Date

2022-06-24

Completion Date

2025-12-31

Last Updated

2024-10-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

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).

Locations (1)

Istituto Auxologico Italiano IRCCS

Milan, Italy