To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France (ECOS FRA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01291394
First received: January 31, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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™.


Condition Intervention
Growth Disorders
Device: Easypod™

Study Type: Observational
Study Design: Observational Model: Cohort
Official 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mean percent of recorded adherence [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Subject adherence profile [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
    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

  • Correlation of adherence with IGF-1 levels/ranges [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Easypod™
    Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
    Other Name: Somatotropin
Detailed Description:

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
  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

Subjects who are taking SAIZEN® for a pediatric registered indications using the Easypod™ electromechanical device.

Criteria

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
  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: NCT01291394

Contacts
Contact: Merck KGaA Communication Center +49-6151-72-5200 service@merckgroup.com

Locations
France
For Recruiting Recruiting
Locations in, France
Contact: Merck KGaA Communication Center    +49-6151-72-5200    service@merckgroup.com   
Sponsors and Collaborators
Merck KGaA
Merck Serono S.A.S, France
Investigators
Study Director: Medical Director MGS Division, Merck Serono s.a.s, France, an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01291394     History of Changes
Other Study ID Numbers: EMR 200104-515
Study First Received: January 31, 2011
Last Updated: December 12, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: French Data Protection Authority

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 July 29, 2014