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

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

223 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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This is 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 from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

Detailed Description

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Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.

Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height \& weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.

Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device 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 Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving Saizen® via Easypod™
* To identify adherence subject profiling
* To asses the Impact of adherence on insulin-like growth factor-1 (IGF1) ranges/levels

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 Saizen® via the Easypod™ electromechanical device according to pediatric registered indications (Growth Hormone Deficiency, Small for Gestational Age, Turner-Syndrome or prepubertal children with Chronic Renal Failure).
* Naïve subjects or already treated with Saizen and Easypod for maximum 1 year
* Male and Female between 2 - 18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's (or subject if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care.

Exclusion Criteria

* Subjects taking Saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects)
* Contra-indications to Saizen® as defined in the French Summary of Product Characteristics (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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

MGS Division, Merck Serono s.a.s, France, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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Contact Merck KGaA

Communication Center, , France

Site Status

Countries

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France

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.