An observational study in Growth Disorders, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Korea, Republic of. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by Merck KGaA, Darmstadt, Germany · Observational
This is 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 from hospital in Korea in order to assess the level of adherence of subjects receiving SAIZEN® via easypod™.
Subjects will be enrolled in a multicenter, longitudinal, observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program designed to improve their adherence 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 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:
167 studies on the registry are indexed under Growth Disorders; 24 are open to participants now.
This study's enrollment of 224 is close to the median of 205 across 67 observational studies indexed under Growth Disorders.
Browse Growth Disorders studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.
Exclusion Criteria:
Mean percent of adherence by subject over a period of time
Time frame: At least 6 months and up to 5 years
Correlation of adherence and growth outcome (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height standard deviation score) after each year of SAIZEN® treatment with easypod™
Time frame: At least 6 months and up to 5 years
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
Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™
Time frame: At least 6 months and up to 5 years
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany