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

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.

Recruiting

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Key information

Conditions

Dwarfism, Pituitary Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shivajoyti Clinic, Bengaluru, Karnataka, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Somatrogon

Drug

Long-acting growth hormone for pediatric growth hormone deficiency.

Primary outcomes

Number of adverse events in participants on Somatrogon

Time frame: 3 years

Secondary outcomes

Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence

Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2028
First posted: Sep 19, 2024
Registry last updated: Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed