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

Merck KGaA, Darmstadt, Germany220 enrolled

Overview

This is an Italian, 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 or guardian and subjects (when applicable) will provide their Informed Consent 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 Objectives: * To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™ * To identify adherence subject profiling * 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

220

Conditions

Growth Disorders

Interventions

Device: easypod™DEVICE

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Over the age of \>2 years * Under \<18 years of age, or over 18 without fusion of growth plates * Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given 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 Summary of Product Characteristics (SmPC) * Use of an investigational drug or participation in another interventional clinical study

Locations (1)

For Locations in Italy

Please Contact the Merck KGaA Communication Center, Italy

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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