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To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ (ECOS Taiwan, Indonesia, Singapore)

Easypod Connect: a Multinational, Multicentre, Observational Study to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "easypodTM" Electromechanical Device for Growth Hormone Treatment

NCT02015273•Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

This is an Multinational, Multicenter, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Detailed Description

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects will provide their Informed Consent/assent 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 both 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 * To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is, above, below or within normal ranges)

Eligibility

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristic (SmPC)
•Over the age of 2 years
•Under 18 years of age, or over 18 without fusion of growth plates
•Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country

Exclusion Criteria

•Subjects taking growth hormone in whom growth plates have fused (that is, for taking growth hormone for it's metabolic effects)
•Contra-indications to SAIZEN® as defined in the SmPC
•Use of an investigational drug or participation in another interventional clinical study

Locations (6)

Anakku Clinic Pondok Pinang

Jakarta, Indonesia

KK Women's & Children's Hospital

Singapore, Singapore

National University Hospital

Singapore, Singapore

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Key Dates

Start Date

February 28, 2014

Primary Completion Date

December 31, 2015

Completion Date

December 31, 2015

Last Updated

July 7, 2020

Enrollment

ACTUAL participants

Conditions

Growth Disorders

Interventions

easypod™

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ (ECOS Taiwan, Indonesia, Singapore)

Inclusion Criteria

Exclusion Criteria

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