NCT01291394

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 223 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

Detailed description

Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF. Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height \& weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes. Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device 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) ranges/levels

Conditions

• Growth Disorders

Interventions

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

Timeline

• Start date: 2011-01-31
• Primary completion: 2015-12-31
• Completion: 2015-12-31
• First posted: 2011-02-08
• Last updated: 2017-12-26

Locations

1 site across 1 country: France