- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267526
A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Pediatric Subjects Using SAIZEN® Via Easypod™ Auto-injector for Growth Hormone Treatment (ECOS CAN)
"Easypod™ Connect Registry": A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of SAIZEN® in Pediatric Subjects Using Easypod™ Auto-injector
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 prescribed SAIZEN® via easypod™
Secondary Objectives:
- To describe the impact of adherence on clinical outcomes for subject prescribed SAIZEN via easypod™
- To identify adherence subject profiling
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada
- Merck Serono Research Site
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Edmonton, Alberta, Canada
- Merck Serono Research Site
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British Columbia
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North Vancouver, British Columbia, Canada
- Merck Serono Research Site
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Vancouver, British Columbia, Canada
- Merck Serono Research Site
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Ontario
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Hamilton, Ontario, Canada
- Merck Serono Research Site
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London, Ontario, Canada
- Merck Serono Research Site
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Toronto, Ontario, Canada
- Merck Serono Research Site
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Quebec
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Montréal, Quebec, Canada
- Merck Serono Research Site
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Sherbrooke, Quebec, Canada
- Merck Serono 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:
- Prescribed SAIZEN® via the easypod™ auto-injector (SAIZEN® Health Canadian approved indications: Growth Hormone Insufficiency or Deficiency, Turner's Syndrome, Chronic Renal Failure, Small for Gestational Age
- Under 18 years of age, or over 18 without fusion of growth plates
- Parent's or legal guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/legal 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 by Health Canada regulations. Adult consent is defined at 18+ in the province of Quebec, 16+ in the remainder of Canada.
Exclusion Criteria:
- Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for its metabolic effects)
- Contra-indications to SAIZEN® as defined in SAIZEN® Canadian Product Monograph.
- Use of an investigational drug or participation in another interventional clinical study
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
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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Adherence will be defined as 86 percent adherent at one year based on prescribed therapy.
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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 |
---|---|---|
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 (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, change in height (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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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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Collaborators and Investigators
Sponsor
Collaborators
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
- EMR200104-517
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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