- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402999
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Hungary (ECOS HUN)
Easypod Connect: A National, Multicentre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment in Hungary
Study Overview
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 retrospectively and prospectively. This will allow the establishment of adherence profiles 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 Objective:
- To identify adherence subject profiling
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
- To asses the impact of adherence on Insulin-like Growth Factor-1 (IGF-1) (i.e. above, below or within normal ranges)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Please Contact The Merck KGaA Communication Center, Hungary
- For Recruiting Locations in Hungary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Administered growth hormone via the easypod™ electromechanical device according to the Summary of Product Characteristics (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.
Exclusion Criteria:
- Subjects taking growth hormone in whom growth plates have fused (i.e. 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 an interventional clinical study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean percent of daily recorded adherence
Time Frame: At least 6 months and up to 5 years
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At least 6 months and up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment
Time Frame: At least 6 months and up to 5 years
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At least 6 months and up to 5 years
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Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)
Time Frame: At least 6 months and up to 5 years
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At least 6 months and up to 5 years
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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
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Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score (height SDS)) after each year of SAIZEN® treatment with easypod™
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At least 6 months and up to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Director, Merck Kft., Hungary
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR200104-528
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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