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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01439061
Other study ID # EMR200104-529
Secondary ID
Status Completed
Phase N/A
First received September 21, 2011
Last updated December 22, 2017
Start date March 31, 2012
Est. completion date December 31, 2015

Study information

Verified date December 2017
Source Merck KGaA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an Italian, 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™.


Description:

Subjects will be enrolled in a multicenter longitudinal observational study. Parents or guardian and subjects (when applicable) will provide their Informed Consent 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 Objectives:

- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™

- To identify adherence subject profiling

- To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date December 31, 2015
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- Over the age of >2 years

- Under <18 years of age, or over 18 without fusion of growth plates

- Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given

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 another interventional clinical study

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy For Locations in Italy Please Contact The Merck KGaA Communication Center

Sponsors (2)

Lead Sponsor Collaborator
Merck KGaA Merck Serono S.P.A., Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 Interna

Outcome

Type Measure Description Time frame Safety issue
Primary Mean percent of daily recorded adherence At least 6 months and up to 5 years
Secondary Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ 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™ At least 6 months and up to 5 years
Secondary Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment At least 6 months and up to 5 years
Secondary Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) At least 6 months and up to 5 years
See also
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