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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Growth Disorders

Treatments: Device: easypod™

Study type: Observational

Funder types: Industry

Identifiers

NCT01309555

EMR 200104-521

Details and patient eligibility

About

This is an Australian, Multicentre, Observational Registry 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 registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased 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:

• To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
• To identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
• To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (above, below or within normal ranges)

Enrollment: 33 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Administered growth hormone via the easypod™ electromechanical device according to the SAIZEN® Product Information
• Aged between 2 and 18 years
• Appropriate Informed Consent/Assent provided

Exclusion criteria

• Subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects)
• Contra-indications to SAIZEN® as defined in SAIZEN® Product Information
• Use of an investigational drug or participation in another interventional clinical trial