ECOS CAN: 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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01267526

Collaborator

EMD Serono, a division of EMD Inc., Canada (Industry)

205

Enrollment

Locations

Actual Duration (Months)

22.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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™ .

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders	Device: Easypod™

Detailed 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

Study Design

Study Type:

Observational

Actual Enrollment :

205 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 31, 2011

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Dec 31, 2015

Outcome Measures

Primary Outcome Measures

Mean percent of adherence by subject over a period of time [At least 6 months and up to 5 years]
Adherence will be defined as 86 percent adherent at one year based on prescribed therapy.

Secondary Outcome Measures

Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [At least 6 months and up to 5 years]
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™
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [At least 6 months and up to 5 years]
Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™ [At least 6 months and up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Merck Serono Research Site	Calgary	Alberta	Canada
2	Merck Serono Research Site	Edmonton	Alberta	Canada
3	Merck Serono Research Site	North Vancouver	British Columbia	Canada
4	Merck Serono Research Site	Vancouver	British Columbia	Canada
5	Merck Serono Research Site	Hamilton	Ontario	Canada
6	Merck Serono Research Site	London	Ontario	Canada
7	Merck Serono Research Site	Toronto	Ontario	Canada
8	Merck Serono Research Site	Montréal	Quebec	Canada
9	Merck Serono Research Site	Sherbrooke	Quebec	Canada