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

• ClinicalTrials.gov Identifier: NCT01400984
• Recruitment Status: Completed
• First Posted: July 25, 2011
• Last Update Posted: December 26, 2017
• Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborator: Merck spol. s r.o., Slovakia
• Information provided by (Responsible Party): Merck KGaA, Darmstadt, Germany

Tracking Information

• First Submitted Date: July 21, 2011
• First Posted Date: July 25, 2011
• Last Update Posted Date: December 26, 2017
• Actual Study Start Date: December 31, 2011
• Actual Primary Completion Date: December 31, 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 22, 2011): Mean percent of daily recorded adherence [ Time Frame: At least 6 months and up to 5 years ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01400984 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 22, 2011)

• 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 ]
  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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Slovakia
• 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 Slovakia
• Brief Summary: This is a Slovakian, 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™.

Detailed Description

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)

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the easypod™ electromechanical device.
• Condition: Growth Disorders

Intervention

Device: easypod™

Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™

Other Name: Somatotropin

• Study Groups/Cohorts: Not Provided

Publications *

• Koledova, E. et al. (2017) Analysis of results from the global, 5-year Easypod™ Connect Observational Study (ECOS) study in children with growth disorders. 10th International Meeting for Pediatric Endocrinology; 2017 Sep 14-17; Washington, DC.
• Wit, JM. et al. (2017) Effect of adherence on the 2-year growth response to growth hormone treatment in prepubertal children with idiopathic isolated growth hormone deficiency participating in the EasypodTM Connect Observational Study (ECOS). 10th International Meeting of Paediatric Endocrinology; 2017 Sep 14-17; Washington, DC.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2016): 92
• Original Estimated Enrollment (submitted: July 22, 2011): 250
• Actual Study Completion Date: December 31, 2015
• Actual Primary Completion Date: December 31, 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Slovakia

Administrative Information

• NCT Number: NCT01400984
• Other Study ID Numbers: EMR200104-526
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merck KGaA, Darmstadt, Germany
• Study Sponsor: Merck KGaA, Darmstadt, Germany
• Collaborators: Merck spol. s r.o., Slovakia

Investigators

• Study Director: Medical Director; Merck spol. s r.o., Slovakia

• PRS Account: Merck KGaA, Darmstadt, Germany
• Verification Date: December 2017