Actively Recruiting
A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
Led by Pfizer · Updated on 2026-06-05
50
Participants Needed
4
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prescription of Somatrogon for p GHD in participants aged 3 years or more.
- Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care.
You will not qualify if you...
- Participation in any interventional clinical trials at the time of enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Shivajoyti Clinic
Bengaluru, Karnataka, India, 560008
Actively Recruiting
2
Apollo Children's Hospital
Chennai, Tamil Nadu, India, 600006
Actively Recruiting
3
G Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, India, 641037
Actively Recruiting
4
Apollo Speciality Hospital
Madurai, Tamil Nadu, India, 625020
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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