Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT01897766
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2013-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
AN INVESTIGATION INTENDED TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF GENOTROPIN IN CHILDREN WITH SGA DWARFISM WITHOUT EPIPHYSEAL CLOSURE. (RETROSPECTIVE STUDY)
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
Detailed Description:
All the patients whom an investigator prescribes Genotropin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: