Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT01439061
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2011-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
Sponsor:
Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECOS ITA
Brief 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)
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)
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: