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OpenTrials
Completed

NCT Number: NCT01291394

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

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 France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Contact Merck KGaA

Communication Center, France

About this study

Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.

Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height & weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.

Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles 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 describe the impact of adherence on clinical outcomes for subject receiving Saizen® via Easypod™
  • To identify adherence subject profiling
  • To asses the Impact of adherence on insulin-like growth factor-1 (IGF1) ranges/levels

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Administered Saizen® via the Easypod™ electromechanical device according to pediatric registered indications (Growth Hormone Deficiency, Small for Gestational Age, Turner-Syndrome or prepubertal children with Chronic Renal Failure).
  • Naïve subjects or already treated with Saizen and Easypod for maximum 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 if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care.

Exclusion criteria

  • Subjects taking Saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects)
  • Contra-indications to Saizen® as defined in the French Summary of Product Characteristics (SmPC)
  • Use of an investigational drug or participation in an interventional clinical study

Treatment and study plan

Easypod™

Device

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

Other names: Somatotropin

Primary outcomes

  1. Mean percent of recorded adherence

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

Secondary outcomes

  1. Correlation of adherence and growth outcome (change in height velocity (HV), change in HV-Standard Deviation Score (HV-SDS), change in height-Standard Deviation Score) after each year of Saizen® treatment with Easypod™

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

  2. Subject adherence profile

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

    Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment, administration regimen (6 or 7 days/ week), combination of pituitary hormone deficiencies, previous and/or concomitant treatments, socio-economic data

  3. Correlation of adherence with IGF-1 levels/ranges

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

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono S.A.S, France

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

Acronym: ECOS FRA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 8, 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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