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

Sponsor
Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Completed
CT.gov ID
NCT01363674
Collaborator
Merck A.E., Greece (Industry)
180
1
32
5.6

Study Details

Study Description

Brief Summary

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™.

Condition or Disease Intervention/Treatment Phase
  • Device: Easypod™

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 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)

Study Design

Study Type:
Observational
Actual Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Other
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 in Greece
Actual Study Start Date :
Apr 30, 2013
Actual Primary Completion Date :
Dec 31, 2015
Actual Study Completion Date :
Dec 31, 2015

Outcome Measures

Primary Outcome Measures

  1. Mean percent of adherence by subject [At least 6 months and up to 5 years]

Secondary Outcome Measures

  1. Correlation of adherence and growth outcome after each year of SAIZEN® treatment with Easypod™ [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 [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) [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™. [At least 6 months and up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 For Recruiting Locations in Greece, Please Contact The Merck KGaA Communication Center Greece

Sponsors and Collaborators

  • Merck KGaA, Darmstadt, Germany
  • Merck A.E., Greece

Investigators

  • Study Director: Medical Director, Merck A.E., Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:
NCT01363674
Other Study ID Numbers:
  • EMR 200104-520
First Posted:
Jun 1, 2011
Last Update Posted:
Dec 26, 2017
Last Verified:
Dec 1, 2017
Keywords provided by Merck KGaA, Darmstadt, Germany
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 26, 2017