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NCT Number: NCT01363674

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

This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in Greece and to assess the level of adherence of subjects 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

For Recruiting Locations in Greece,

Please Contact the Merck KGaA Communication Center, Greece

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 receiving SAIZEN® via Easypod™

Secondary Objectives:

  • To identify adherence subject profiling
  • To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via Easypod™
  • To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)
  • To assess/describe the impact of the Greek Scientific Service (Patient Support Program)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Administered growth hormone (SAIZEN®) via the Easypod™ auto-injector, according to approved Summary of Product Characteristics (SmPC)
  • Naïve subjects or already treated with SAIZEN® and Easypod™ for up to 1 year
  • Male and female between 2 - 18 years of age, or over 18 without fusion of growth plates
  • Parent's or guardian's (or subject's if over 18 without fusion of growth plates) written informed consent, given before entering data into the registry, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

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

Treatment and study plan

Easypod™

Device

Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™

Other names: Saizen, Somatotropin

Primary outcomes

  1. Mean percent of adherence by subject

    Time frame: At least 6 months and up to 5 years

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. Correlation of adherence with current IGF-I status (i.e. above, below or within normal ranges)

    Time frame: At least 6 months and up to 5 years

  4. Impact of Greek Scientific Service (Patient Support Program) 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

  • Merck A.E., Greece

Registry information

Official study title

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

Acronym: ECOS GRE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2011
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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