Status:
COMPLETED
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.P.A., Italy
Conditions:
Growth Disorders
Eligibility:
All Genders
2-18 years
Brief 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...
Detailed 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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01439061
Start Date
March 31 2012
End Date
December 31 2015
Last Update
December 26 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
For Locations in Italy
Please Contact the Merck KGaA Communication Center, Italy