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NCT06587035 | RECRUITING | Dwarfism, Pituitary

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

Pfizer

Brief 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.

Condition or disease

Dwarfism, Pituitary

Intervention/treatment

Somatrogon

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
Actual Study Start Date : 2025-01-30
Estimated Primary Completion Date : 2026-09-21
Estimated Study Completion Date : 2028-09-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 3 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.

Location Details

NCT06587035

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

India, Karnataka

Shivajoyti Clinic

Bengaluru, Karnataka, India, 560008

RECRUITING

India, Tamil Nadu

Apollo Children's Hospital

Chennai, tamil nadu, India, 600006

RECRUITING

India, Tamil Nadu

G Kuppuswamy Naidu Memorial Hospital

Coimbatore, tamil nadu, India, 641037

RECRUITING

India, Tamil Nadu

Apollo Speciality Hospital

Madurai, tamil nadu, India, 625020