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

Growth Disorders Clinical Trial

— ECOS CAN  

Official title:

"Easypod™ Connect Registry": A Canadian, Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of SAIZEN® in Pediatric Subjects Using Easypod™ Auto-injector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267526
• Other study ID #: EMR200104-517
• Status: Completed
• Phase: N/A
• First received: December 27, 2010
• Last updated: December 22, 2017
• Start date: May 31, 2011
• 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 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™ .

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• 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:

• 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

Related Conditions & MeSH terms

• Growth Disorders

Intervention

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

Locations

Country	Name	City	State
Canada	Merck Serono Research Site	Calgary	Alberta
Canada	Merck Serono Research Site	Edmonton	Alberta
Canada	Merck Serono Research Site	Hamilton	Ontario
Canada	Merck Serono Research Site	London	Ontario
Canada	Merck Serono Research Site	Montréal	Quebec
Canada	Merck Serono Research Site	North Vancouver	British Columbia
Canada	Merck Serono Research Site	Sherbrooke	Quebec
Canada	Merck Serono Research Site	Toronto	Ontario
Canada	Merck Serono Research Site	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	EMD Serono, a division of EMD Inc., Canada

Country where clinical trial is conducted

Canada, 

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	Adherence will be defined as 86 percent adherent at one year based on prescribed therapy.	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 (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