Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic (ECOS CZ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merck KGaA
Sponsor:
Collaborator:
Merck spol.s.r.o., Czech Republic
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01400997
First received: July 21, 2011
Last updated: August 1, 2014
Last verified: August 2014

July 21, 2011
August 1, 2014
September 2011
December 2015   (final data collection date for primary outcome measure)
Mean percent of daily recorded adherence [ 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 NCT01400997 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 (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(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 [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
  • Correlation of adherence with current IGF-1 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 (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(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 [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: Yes ]
  • Correlation of adherence with current IGF-1 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
 
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic
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 Czech Republic

This is Multicentre, Observational Study 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 study. Parents/ subjects will provide their Informed Consent/assent to upload their data for population-based analyses 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 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 Objective:

  • 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)
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 (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
Other Name: Somatotropin
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
140
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 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 observational study, 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 it's metabolic effects)
  • Contra-indications to SAIZEN® as defined in the SmPC
  • Use of an investigational drug or participation in an interventional clinical study
Both
2 Years to 18 Years
No
Contact: Merck KGaA Communication Center +49-6151-72-5200 service@merckgroup.com
Czech Republic
 
NCT01400997
EMR200104-527
No
Merck KGaA
Merck KGaA
Merck spol.s.r.o., Czech Republic
Study Director: Medical Director Merck spol.s.r.o., Czech Republic
Merck KGaA
August 2014

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