Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
Study NCT ID:
NCT05602766
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ngenla Subcutaneous Injection Special Investigation
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Ngenla® Subcutaneous Injection Special Investigation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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 purpose of this study is to learn about the long-term safety and effects of Ngenla. Ngenla is approved for treatment of GHD (Growth hormone deficiency) without epiphyseal closure under daily medical practice.
Registration criteria of this study are the patients who:
* Have GHD without epiphyseal closure and receiving Ngenla for the first time.
* Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
Registration criteria of this study are the patients who:
* Have GHD without epiphyseal closure and receiving Ngenla for the first time.
* Are boys less than 15 years or girls less than 13 years of age at the start of treatment with Ngenla.
All patients in this study will receive Ngenla according to the prescriptions. We will examine their experiences for a long time. This will help us to determine the safety and effects of Ngelna for long-term use.
Patients will be followed up from the date of first Ngenla treatment until November 30, 2027.
Detailed Description:
This is a multi-center cohort study in patients with GHD without epiphyseal closure receiving NGENLA® Subcutaneous Injection. The investigators complete the case report form (CRF) based on the information extracted from the medical record created in daily medical practice.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: