Status:
RECRUITING
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Lead Sponsor:
Ipsen
Conditions:
IGF1 Deficiency
Eligibility:
All Genders
2-18 years
Brief Summary
The Increlex® Global Registry is a descriptive, multicenter, observational, prospective, open-ended, non interventional, post-authorisation surveillance registry. The main purpose of this global regi...
Detailed Description
This registry is a Post-Authorisation Safety Study called the Increlex® Global Registry which is intended primarily to monitor the safety of Increlex® therapy in children and adolescents with Severe P...
Eligibility Criteria
Inclusion
- For US : patients starting or planning to start or currently receiving treatment with Increlex® therapy for severe primary IGF-1 deficiency as defined by the US Increlex® prescribing information or for growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.For EU : patients starting or planning to start or currently receiving treatment with Increlex® therapy according to the locally approved product information.
- Parents or legally authorized representatives if applicable must give signed informed consent before any registry-related activities are conducted. Assent from the subject should also be obtained as appropriate
Exclusion
- Subject currently participating in an Increlex® clinical trial
- Subject currently participating in any clinical trial for growth retardation
- Patient with any contraindication to Increlex® or any condition subject to special warning as per the locally approved label
- For US patients, these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia and patients with closed epiphyses.
- For EU patients: these include patients with hypersensitivity to the active substance or any of the excipients, patients with active or suspected neoplasia or any condition or medical history which increases the risk of benign or malignant neoplasia and patients with closed epiphyses
Key Trial Info
Start Date :
December 9 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00903110
Start Date
December 9 2008
End Date
December 31 2027
Last Update
November 28 2025
Active Locations (58)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
University of Miami Leonard M Miller
Miami, Florida, United States, 33136
3
University Of Miami Leonard M. Miller
Miami, Florida, United States, 33136
4
D&H National Research Centers
Miami, Florida, United States, 33155