A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
- Dwarfism, Pituitary
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Pfizer
- Enrolment target
- 50
- Started
- 30 January 2025
- Main results due
- 21 September 2026
- Study sites
- 4
- Registry updated
- 24 September 2026
Can you take part?
- Ages 3 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(4)
Shivajoyti Clinic
Bengaluru, Karnataka, India
Recruiting
Apollo Children's Hospital
Chennai, Tamil Nadu, India
Recruiting
G Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, India
Recruiting
Apollo Speciality Hospital
Madurai, Tamil Nadu, India
Recruiting
Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06587035. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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