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

Overview

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 Title of Study: “Easypod Connect: An Australian Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: December 31, 2015

Detailed 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)

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • Mean percent of adherence by subject
    • Time Frame: At least 6 months and up to 5 years

Secondary Measures

  • Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™
    • Time Frame: At least 6 months and up to 5 years
    • Correlation of adherence and growth outcome (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, change in height (height SDS) after each year of SAIZEN® treatment with easypod™
  • Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment with easypod™
    • Time Frame: At least 6 months and up to 5 years
  • Correlation of adherence with current IGF-I status (i.e. above, below or within normal ranges)
    • Time Frame: At least 6 months and up to 5 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck KGaA, Darmstadt, Germany
  • Collaborator
    • Merck Serono Australia Pty Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Responsible, Study Director, Merck Serono Australia Pty Ltd

Citations Reporting on Results

Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

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