To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy (ECOS ITA)

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Growth Disorders

Treatments: Device: Device: easypod™

Study type: Observational

Funder types: Industry

Identifiers

NCT01439061

EMR200104-529

Details and patient eligibility

About

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™.

Full description

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)

Enrollment: 220 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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