Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587035
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency p GHD in India
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 safety of Somatrogon for the treatment of pediatric growth hormone deficiency p GHD in India
Pediatric GHD is a condition caused by too less amounts of growth hormone in the body Children with GHD have a short height GHD can be present at birth or develop later The condition occurs if the pituitary gland makes too little growth hormone This is a small gland at the bottom of the brain that releases hormones that affect growth and other body functions
This study is seeking for participants who are
confirmed with p GHD
given Somatrogon to be taken as an injection
The safety of Somatrogon injection will be checked based on side effects These side effects can happen within 3 years after taking Somatrogon A side effect is something expected or unexpected that you feel was caused by a medicine or treatment you take The study doctor will collect side effect information and put the information on patients case form
Follow-up of the patients will be performed via clinic re-visit or over a call It is not a rule for the participants to visit the clinic in this study
This study will help to see if Somatrogon is safe
Pediatric GHD is a condition caused by too less amounts of growth hormone in the body Children with GHD have a short height GHD can be present at birth or develop later The condition occurs if the pituitary gland makes too little growth hormone This is a small gland at the bottom of the brain that releases hormones that affect growth and other body functions
This study is seeking for participants who are
confirmed with p GHD
given Somatrogon to be taken as an injection
The safety of Somatrogon injection will be checked based on side effects These side effects can happen within 3 years after taking Somatrogon A side effect is something expected or unexpected that you feel was caused by a medicine or treatment you take The study doctor will collect side effect information and put the information on patients case form
Follow-up of the patients will be performed via clinic re-visit or over a call It is not a rule for the participants to visit the clinic in this study
This study will help to see if Somatrogon is safe
Detailed Description:
None
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?: