Growth Disorders Clinical Trial
Official title:
Easypod Connect: a Multinational, Multicentre, Observational Study to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "easypodTM" Electromechanical Device for Growth Hormone Treatment
This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via easypod™.
Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
will provide their Informed Consent/assent to upload their data for population-based analyses
and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
easypod™ device combined with physician data entry of outcome measures. Data will be
collected both retrospectively and prospectively. This will allow the establishment of
adherence profiles and explore the hypothesis that patient adherence support programs improve
adherence and subsequent clinical outcomes. Collected data will be also analyzed in a
multinational pooled analysis of comparable national studies.
Primary Objective:
• To assess the level of adherence of subjects receiving SAIZEN® via easypod™
Secondary Objectives:
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
via easypod™
- To identify adherence subject profiling
- To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is,
above, below or within normal ranges)
;
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