Growth Disorders Clinical Trial
Official title:
Easypod Connect: A Regional, Multicentre, Observational Study to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment
This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via easypod™.
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 both retrospectively and prospectively. This will allow the establishment of
adherence profiles and explore the hypothesis that patient adherence support programs improve
adherence 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 assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is,
above, below or within normal ranges)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01376921 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Spain
|
N/A | |
| Completed |
NCT01400997 -
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic
|
N/A | |
| Completed |
NCT05244785 -
Health and Nutrition Survey on Shenzhen Children
|
||
| Completed |
NCT00097539 -
A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin
|
Phase 4 | |
| Not yet recruiting |
NCT04576845 -
The Effect of Early Childhood Cow's Milk Allergy Elimination Diet on Eating Behaviors, Nutrition, and Growth Status
|
||
| Not yet recruiting |
NCT05056285 -
Pattern of Growth and Characteristics of Down Syndrome Pediatrics Patients
|
||
| Completed |
NCT01263457 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
|
||
| Terminated |
NCT00330668 -
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
|
Phase 3 | |
| Completed |
NCT00378859 -
The Effect of Milk and Meat on IGFs in Prepubertal Boys
|
N/A | |
| Not yet recruiting |
NCT05577130 -
Growth Pattern and Characteristics of Cardiac Pediatric Patients
|
||
| Recruiting |
NCT05033119 -
PROSA: Prolactin, Sex Hormones, Growth and Metabolic Biomarkers in Children and Adolescents on Antipsychotics
|
||
| Completed |
NCT01402999 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary
|
N/A | |
| Completed |
NCT01267526 -
A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment
|
N/A | |
| Completed |
NCT00139451 -
Nutrients and Hormones: Effects in Boys With Disordered Growth
|
Phase 2 | |
| Terminated |
NCT03274973 -
Study to Assess Long-term Effectiveness of Zomacton® and Treatment Adherence in Patients With Growth Hormone Deficiency or Ullrich-Turner Syndrome
|
||
| Completed |
NCT01582334 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Argentina
|
N/A | |
| Completed |
NCT01439061 -
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
|
N/A | |
| Completed |
NCT00125164 -
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
|
Phase 3 | |
| Completed |
NCT00174408 -
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
|
Phase 3 | |
| Recruiting |
NCT05829252 -
Testing the Feasibility of a Novel Growth Monitoring Smartphone App
|