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 (ECOS CAN)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
EMD Serono, a division of EMD Inc., Canada
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01267526
First received: December 27, 2010
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention
Growth Disorders
Device: Easypod™

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean percent of adherence by subject over a period of time [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
    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™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
  • Impact of patient adherence support programme on adherence and outcomes for subjects using easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: May 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Easypod™
    Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph
    Other Names:
    • Saizen
    • Somatropin
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
  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects 18 and under who are prescribed SAIZEN® (Health Canada approved indications) using the easypod™ auto-injector.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267526

Locations
Canada, Alberta
Merck Serono Research Site
Calgary, Alberta, Canada
Merck Serono Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Merck Serono Research Site
North Vancouver, British Columbia, Canada
Merck Serono Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Merck Serono Research Site
Hamilton, Ontario, Canada
Merck Serono Research Site
London, Ontario, Canada
Merck Serono Research Site
Toronto, Ontario, Canada
Canada, Quebec
Merck Serono Research Site
Montréal, Quebec, Canada
Merck Serono Research Site
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Merck KGaA
EMD Serono, a division of EMD Inc., Canada
Investigators
Study Director: Medical Responsible EMD Serono, a division of EMD Inc., Canada
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01267526     History of Changes
Other Study ID Numbers: EMR200104-517
Study First Received: December 27, 2010
Last Updated: August 1, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Merck KGaA:
Growth disorders
Saizen
Easypod
Growth hormone
Pediatric subject

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014