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NCT Number: NCT01267526

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

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™ .

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Key information

Conditions

Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Merck Serono Research Site, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Easypod™

Device

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

Other names: Saizen, Somatropin

Primary outcomes

  1. Mean percent of adherence by subject over a period of time

    Time frame: 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 outcomes

  1. 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

    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™

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • EMD Serono, a division of EMD Inc., Canada

Registry information

Official study 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

Acronym: ECOS CAN

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2010
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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