Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic

Merck KGaA, Darmstadt, Germany206 enrolled

Overview

This is 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/ 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 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 Objective: * To identify adherence subject profiling * To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™ * To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Study Type

OBSERVATIONAL

Enrollment

206

Conditions

Growth Disorders

Interventions

easypod™DEVICE

Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) 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 the Summary of Product Characteristics (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. 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 an interventional clinical study

Locations (1)

For Recruiting Locations in Czech Republic

Please Contact the Merck KGaA Communication Center, Czechia

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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