A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.

NCT06587035 · tracked via the Priya Life Science India tracker

Sponsor

Pfizer

Phase

Observational

Started

2025-01-30

Last updated

2026-08-14

Condition(s) studied

Dwarfism, Pituitary

Investigational drug(s) / intervention(s)

Somatrogon

Somatrogon: Long-acting growth hormone for pediatric growth hormone deficiency.

Study 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.

Eligibility

Sex

ALL

Min age

3 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Participation in any interventional clinical trials at the time of enrollment.

Primary outcome measure(s)

Number of adverse events in participants on Somatrogon — 3 years

Trial sites (4)

Facility	City	Region	Status
Shivajoyti Clinic	Bengaluru	Karnataka	Recruiting
Apollo Children's Hospital	Chennai	Tamil Nadu	Recruiting
G Kuppuswamy Naidu Memorial Hospital	Coimbatore	Tamil Nadu	Recruiting
Apollo Speciality Hospital	Madurai	Tamil Nadu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06587035 on ClinicalTrials.gov ↗ ← All trials in India