To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in South Korea (ECOS KOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Ltd.
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01259778
First received: December 13, 2010
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 hospital in Korea in order to assess the level of adherence of subjects receiving SAIZEN® via easypod™.


Condition
Growth Disorders

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 adherence by subject over a period of time [ 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 (height velocity (HV), height velocity-standard deviation score (HV-SDS), height, 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 based on age, gender, indication, self-injection or not, time on treatment [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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 population-based 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 describe the impact of adherence on clinical outcomes for subject receiving SAIZEN via easypod™
  • To identify adherence subject profiling
  • To assess the impact of adherence on Insulin-like growth factor 1 (IGF-1) (i.e. above, below or within normal ranges)
  • Temporal profile of IGF-1 and IGFBP-3 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

Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.

Criteria

Inclusion Criteria:

  • Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristics (SmPC)
  • Over the age of >2 years
  • Under <18 years of age, or over 18 without fusion of growth plates
  • Parent's or guardian's 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. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country.

Exclusion Criteria:

  • Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
  • Contra-indications to SAIZEN® as defined in the 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: NCT01259778

Contacts
Contact: Medical Director +82 2 2185 3997

Locations
Korea, Republic of
Yonsei University Colleage of Medicine, Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Ho-Seong Kim, MD       kimho@yuhs.ac   
Principal Investigator: Ho-Seong Kim, MD         
Sponsors and Collaborators
Merck KGaA
Merck Ltd.
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01259778     History of Changes
Other Study ID Numbers: EMR 200104-522
Study First Received: December 13, 2010
Last Updated: December 12, 2013
Health Authority: Korea: Institutional Review Board

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 26, 2014