To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary (ECOS HUN)
This is a Hungarian, 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™.
|Study Design:||Observational Model: Cohort|
|Official Title:||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 in Hungary|
- Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
- Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score (height SDS)) after each year of SAIZEN® treatment with easypod™
- Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
- Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
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 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.
• To assess the level of adherence of subjects receiving SAIZEN® via easypod™.
- To identify adherence subject profiling
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
- To asses the impact of adherence on Insulin-like Growth Factor-1 (IGF-1) (i.e. above, below or within normal ranges)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402999
|Contact: Merck KGaA Communication Centerfirstname.lastname@example.org|
|For Recruiting Locations in Hungary||Recruiting|
|please contact the Merck KGaA Communication Center, Hungary|
|Contact: Merck KGaA Communication Center +49-6151-72-5200 email@example.com|
|Study Director:||Medical Director||Merck Kft., Hungary|