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

Growth Disorders Clinical Trial

— ECOS ITA  

Official title:

Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Italy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439061
• Other study ID #: EMR200104-529
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: December 22, 2017
• Start date: March 31, 2012
• Est. completion date: December 31, 2015

Study information

• Verified date: December 2017
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an Italian, Multicentre, Observational Study 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™.

Description:

Subjects will be enrolled in a multicenter longitudinal observational study. Parents or guardian and subjects (when applicable) will provide their Informed Consent to upload their data for population-based analyses 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 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) (i.e. above, below or within normal ranges)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• 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:

• Over the age of >2 years

• Under <18 years of age, or over 18 without fusion of growth plates

• Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given

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 Summary of Product Characteristics (SmPC)

• Use of an investigational drug or participation in another interventional clinical study

Related Conditions & MeSH terms

• Growth Disorders

Intervention

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

Locations

Country	Name	City	State
Italy	For Locations in Italy	Please Contact The Merck KGaA Communication Center

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono S.P.A., Italy

Country where clinical trial is conducted

Italy, 

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 daily recorded adherence		At least 6 months and up to 5 years
Secondary	Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™	Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(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	Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges)		At least 6 months and up to 5 years