NCT01439061

To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy

Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Italy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Italian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Detailed description

Subjects will be enrolled in a multicenter longitudinal observational study. Parents or guardian and subjects (when applicable) will provide their Informed Consent 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 retrospectively and prospectively. This will allow the establishment of adherence profiles 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 asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Conditions

• Growth Disorders

Interventions

Type	Name	Description
DEVICE	Device: easypod™	Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™

Timeline

• Start date: 2012-03-31
• Primary completion: 2015-12-31
• Completion: 2015-12-31
• First posted: 2011-09-22
• Last updated: 2017-12-26

Locations

1 site across 1 country: Italy