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Clinical trial

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

ID
Name
01C211
Description
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.
Trial arms
Trial start
2022-06-24
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Treatment
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).
Arms:
Hormone replacement therapy with rhGH
Size
10
Primary endpoint
Size of extracellular vesicles
Baseline and after 6 months
Derivational profile of extracellular vesicles
Baseline and after 6 months
Eligibility criteria
Inclusion Criteria: * short stature: ≤ - 3 SD or ≤ -2 SD * growth velocity/year ≤ -1.0 SD for age and sex evaluated at least 6 months apart - peak GH at two different stimulus pharmacological tests \< 8 ng/ml Exclusion Criteria: - presence of organic pathologies at the hypothalamic-pituitary level (assessed by performing brain MRI).
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum/plasma samples'}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-03-08

1 organization

1 product

1 indication

Organization
Istituto Auxologico Italiano
Product
rhGH
Indication
Growth Hormone Deficiency