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To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Sweden

NCT ID: NCT01307059

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

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-12-31

Brief Summary

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This is a Swedish, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment 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 population-based 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 based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Other Objectives:

• To assess the impact of adherence on average blood glucose (HbA1C)

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

OTHER

Interventions

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easypod™

Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™

Intervention Type DEVICE

Other Intervention Names

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Somatotropin

Eligibility Criteria

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Inclusion Criteria

* Administered growth hormone via the EasypodTM electromechanical device according to Summary of Product Characteristics (SmPC)
* Over the age of \> 2 years old
* Under \< 18 years of age, or over 18 years of age without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the registry , 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 (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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck A.B., Sweden

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

Merck A.B., Sweden

Locations

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Merck Serono Research Site

Gothenburg, , Sweden

Site Status

Merck Serono Research Site

Solna, , Sweden

Site Status

Merck Serono Research Site

Uppsala, , Sweden

Site Status

Countries

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Sweden

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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EMR 200104-524

Identifier Type: -

Identifier Source: org_study_id