To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Columbia

N/ACompletedNCT02208076

Merck KGaA, Darmstadt, Germany44 enrolled

Overview

This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric 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) (i.e. above, below or within normal ranges)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Growth Disorders

Interventions

easypod™DEVICE

Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristic (SmPC) * Over the age of \>2 years * Under \<18 years of age, or over 18 without fusion of growth plates * Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country Exclusion Criteria: * Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * Contra-indications to SAIZEN® as defined in the SmPC * Use of an investigational drug or participation in another interventional clinical study

Locations (1)

For Recruiting Locations in Colombia

Please Contact the Merck KGaA Communication Center, Colombia

Outcomes

Primary Outcomes

Mean percent of daily recorded adherence

Time frame: At least 6 months and up to 5 years

Secondary Outcomes

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™

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

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

Data from ClinicalTrials.gov

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