Growth Disorders Clinical Trial
— ECOS ITAOfficial title:
Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Italy
Verified date | December 2017 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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™.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | For Locations in Italy | Please Contact The Merck KGaA Communication Center |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA | Merck Serono S.P.A., Italy |
Italy,
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
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 |
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