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A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
Sponsor: Pfizer
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 patient's case form. Follow-up of the patient's 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.
Official title: A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
Key Details
Gender
All
Age Range
3 Years - 17 Years
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2025-01-30
Completion Date
2028-09-05
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
Somatrogon
Long-acting growth hormone for pediatric growth hormone deficiency.
Locations (4)
Shivajoyti Clinic
Bengaluru, Karnataka, India
Apollo Children's Hospital
Chennai, Tamil Nadu, India
G Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, India
Apollo Speciality Hospital
Madurai, Tamil Nadu, India