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

Growth Disorders Clinical Trial

— ECOS UK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263457
• Other study ID #: EMR 200104-516
• Status: Completed
• Start date: November 30, 2010
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2021
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 hospital in the UK and to assess the level of adherence of subject receiving SAIZEN® via Easypod™.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders

Intervention

Device:
• Easypod
Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod

Locations

Country	Name	City	State
United Kingdom	Research Site	Birmingham	West Midlands
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull
United Kingdom	Research Site	London
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany	Merck Serono Limited, UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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 Interna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent of adherence by subject over a period of time		At least 6 months and up to 5 years
Secondary	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™		At least 6 months and up to 5 years
Secondary	Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment		At least 6 months and up to 5 years
Secondary	Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™		At least 6 months and up to 5 years