- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263457
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK (ECOS UK)
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
Study Overview
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
- To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF-1) (i.e. above, below or within normal ranges)
- To assess the endocrinological profile including Triiodothyronine (T3), Thyroxine (T4), Thyroid-stimulating hormone (TSH), Insulin-like Growth Factor 1 (IGF-1) and Insulin-like Growth Factor-Binding Protein 3(IGFBP-3) levels
- Temporal profile of IGF-1 and IGFBP-3 levels
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Glasgow, United Kingdom, G3 8SJ
- Research Site
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Hull, United Kingdom, HU3 2JZ
- Research Site
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London, United Kingdom, WC1N 1EH
- Research Site
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Sheffield, United Kingdom, S10 2TH
- Research Site
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Research Site
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West Midlands
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Birmingham, West Midlands, United Kingdom, B4 6NH
- Research Site
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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 injection device according to Summary of Product Characteristics (SmPC)
- Over the age of 2 years
- Under 18 years of age, or over 18 without fusion of growth plates (to be confirmed by the Investigator, where relevant)
- Appropriate Informed Consent/Assent provided
Exclusion Criteria:
- Patients 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 or any other condition which precludes the use of SAIZEN in a given patient
- Use of an investigational drug or participation in an interventional clinical trial
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean percent of adherence by subject over a period of time
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 |
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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Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™
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 (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, change in height (height SDS) after each year of SAIZEN® treatment with easypod™
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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Responsible, Merck Serono Limited, UK
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
- EMR 200104-516
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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