Overview

This trial is active, not recruiting.

Condition growth disorders
Treatment easypod™
Sponsor Merck KGaA
Collaborator Merck Serono Australia Pty Ltd
Start date June 2011
End date December 2015
Trial size 33 participants
Trial identifier NCT01309555, EMR 200104-521

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™.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Measure
Mean percent of adherence by subject
time frame: At least 6 months and up to 5 years

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

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

Additional Information

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
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)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Merck KGaA.