Status:
COMPLETED
A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
Lead Sponsor:
Ipsen
Conditions:
Growth Hormone Disorders
Eligibility:
All Genders
Up to 18 years
Brief Summary
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safe...
Detailed Description
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is i...
Eligibility Criteria
Inclusion
- Children of either sex who are treated with NutropinAq® for the treatment of growth failure
- Patients who are willing to comply with follow-up appointments throughout study participation
- Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable
Exclusion
- Patients not treated with NutropinAq®
- Patients with closed epiphyses
- Patients with active neoplasia
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
3690 Patients enrolled
Trial Details
Trial ID
NCT00455728
Start Date
June 1 2006
End Date
December 1 2016
Last Update
January 7 2019
Active Locations (1)
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1
Ipsen Central Contact
Slough, Berkshire, United Kingdom, SL1 3XE