Status:
COMPLETED
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Slovakia
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck spol. s r.o., Slovakia
Conditions:
Growth Disorders
Eligibility:
All Genders
2-18 years
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 t...
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, ultima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01400984
Start Date
December 31 2011
End Date
December 31 2015
Last Update
December 26 2017
Active Locations (1)
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1
For Recruiting Locations in Slovakia
Please Contact the Merck KGaA Communication Center, Slovakia