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| Name | Class |
|---|---|
| Merck Serono S.P.A., Italy | INDUSTRY |
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™.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: easypod™ | Device | Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent of daily recorded adherence | At least 6 months and up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ | 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™ | At least 6 months and up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Serono S.P.A., Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For Locations in Italy | Please Contact the Merck KGaA Communication Center | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC. | ||
| Result | Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC. |
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment | At least 6 months and up to 5 years |
| Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) | At least 6 months and up to 5 years |