Status:
TERMINATED
Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age
Lead Sponsor:
Sandoz
Conditions:
Short Children Born Small for Gestational Age (SGA)
Eligibility:
All Genders
4+ years
Phase:
NA
Brief Summary
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunoge...
Detailed Description
The purpose of this study is 1. to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of g...
Eligibility Criteria
Inclusion
- All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
- Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian
Exclusion
- Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
Key Trial Info
Start Date :
July 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01491854
Start Date
July 20 2009
End Date
October 31 2018
Last Update
August 14 2019
Active Locations (23)
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1
Novartis Investigative Site
Ústí nad Labem, Czech Republic, Czechia, 400 11
2
Novartis Investigative Site
Hradec Králové, Czechia, 500 05
3
Novartis Investigative Site
Prague, Czechia, 150 06
4
Novartis Investigative Site
Tbilisi, Georgia, 144