Clinical Trials Logo

Clinical Trial Summary

This is an Multinational, 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™.


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02015273
Study type Observational
Source Merck KGaA, Darmstadt, Germany
Contact
Status Completed
Phase
Start date February 28, 2014
Completion date December 31, 2015

See also
  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 NCT02015286 - To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East N/A
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