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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merck KGaA
Sponsor:
Collaborator:
Merck Serono Australia Pty Ltd
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01309555
First received: March 3, 2011
Last updated: August 1, 2014
Last verified: August 2014

March 3, 2011
August 1, 2014
April 2011
December 2015   (final data collection date for primary outcome measure)
Mean percent of adherence by subject [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01309555 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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™
  • Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment with easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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™
  • Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment with easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Australia
Easypod Connect: An Australian Multi-centre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment

This is an Australian, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

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 describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
  • To identify adherence subject profiling based on age, gender, self injection or not, time on treatment, medical history at time of enrollment
  • To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (above, below or within normal ranges)
Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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

Growth Disorders
Device: easypod™
Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other Name: Somatropin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
83
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Administered growth hormone via the easypod™ electromechanical device according to the SAIZEN® Product Information
  • Aged between 2 and 18 years
  • Appropriate Informed Consent/Assent provided

Exclusion Criteria:

  • Subjects with mature bone age taking growth hormone (i.e. for taking growth hormone for its metabolic effects)
  • Contra-indications to SAIZEN® as defined in SAIZEN® Product Information
  • Use of an investigational drug or participation in another interventional clinical trial
Both
2 Years to 18 Years
No
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com
Australia
 
NCT01309555
EMR 200104-521
No
Merck KGaA
Merck KGaA
Merck Serono Australia Pty Ltd
Study Director: Medical Responsible Merck Serono Australia Pty Ltd
Merck KGaA
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP