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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01309555

Collaborator

Merck Serono Australia Pty Ltd (Industry)

Enrollment

Location

66.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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™.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders	Device: easypod™

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)

Study Design

Study Type:

Observational

Actual Enrollment :

33 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Apr 30, 2011

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Oct 31, 2016

Outcome Measures

Primary Outcome Measures

Mean percent of adherence by subject [At least 6 months and up to 5 years]

Secondary Outcome Measures

Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [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™ [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) [At least 6 months and up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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