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

Last updated: June 5, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Growth Hormone Deficiencies/abnormalities

Severe Short Stature

Treatment

Somatrogon

Clinical Study ID

NCT06587035
C0311026
  • Ages 3-17
  • All Genders

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 Criteria

Inclusion

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 thatthe participant (or a legally acceptable representative) has been informed and agreeto all pertinent aspects of the study. Assent will also be sought from children ofapplicable age in line with national guidance. In all cases, the treating physicianresponsible for enrolling the participant into the study will assess theappropriateness of gaining assent from a participant (or a legally acceptablerepresentative) at their discretion during routine clinical care.

Exclusion

Exclusion Criteria:

  • Participation in any interventional clinical trials at the time of enrollment.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Somatrogon
Phase:
Study Start date:
January 30, 2025
Estimated Completion Date:
December 24, 2026

Connect with a study center

  • Apollo Children's Hospital

    Chennai, Tamil NADU 600006
    India

    Active - Recruiting

  • G Kuppuswamy Naidu Memorial Hospital

    Coimbatore, Tamil NADU 641037
    India

    Active - Recruiting

  • Apollo Speciality Hospital

    Madurai, Tamil NADU 625020
    India

    Active - Recruiting

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