Status:
COMPLETED
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono Limited, UK
Conditions:
Growth Disorders
Eligibility:
All Genders
2-18 years
Brief Summary
This is 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...
Detailed Description
Subjects will be enrolled in a multicenter longitudinal observational registry. Parents/subjects will provide their Informed Consent/assent to upload their data for populationbased analyses and option...
Eligibility Criteria
Inclusion
- Administered growth hormone via the easypod electromechanical injection device according to Summary of Product Characteristics (SmPC)
- Over the age of 2 years
- Under 18 years of age, or over 18 without fusion of growth plates (to be confirmed by the Investigator, where relevant)
- Appropriate Informed Consent/Assent provided
Exclusion
- Patients 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 or any other condition which precludes the use of SAIZEN in a given patient
- Use of an investigational drug or participation in an interventional clinical trial
Key Trial Info
Start Date :
November 30 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT01263457
Start Date
November 30 2010
End Date
December 31 2015
Last Update
May 5 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Sutton, Surrey, United Kingdom, SM2 5PT
2
Research Site
Birmingham, West Midlands, United Kingdom, B4 6NH
3
Research Site
Glasgow, United Kingdom, G3 8SJ
4
Research Site
Hull, United Kingdom, HU3 2JZ