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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

NCT ID: NCT01267526

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-12-31

Brief Summary

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This is a Canadian, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospital and to assess the level of adherence of subject receiving SAIZEN® via Easypod™ .

Detailed Description

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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

Conditions

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Growth Disorders

Keywords

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Growth disorders Saizen Easypod Growth hormone Pediatric subject

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Easypod™

Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph

Intervention Type DEVICE

Other Intervention Names

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Saizen Somatropin

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono, a division of EMD Inc., Canada

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

EMD Serono, a division of EMD Inc., Canada

Locations

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Merck Serono Research Site

Calgary, Alberta, Canada

Site Status

Merck Serono Research Site

Edmonton, Alberta, Canada

Site Status

Merck Serono Research Site

North Vancouver, British Columbia, Canada

Site Status

Merck Serono Research Site

Vancouver, British Columbia, Canada

Site Status

Merck Serono Research Site

Hamilton, Ontario, Canada

Site Status

Merck Serono Research Site

London, Ontario, Canada

Site Status

Merck Serono Research Site

Toronto, Ontario, Canada

Site Status

Merck Serono Research Site

Montreal, Quebec, Canada

Site Status

Merck Serono Research Site

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT

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.

Reference Type RESULT

Other Identifiers

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EMR200104-517

Identifier Type: -

Identifier Source: org_study_id