Clinical trial NCT06587035: A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
Official title: A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dwarfism, Pituitary
Keywords: Somatrogon, Safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants treated with Somatrogon will be followed by the treating physician as per routine clinical practice, who will collect and enter relevant participant data onto case report forms (CRFs).

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.


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.

Primary outcomes:
measure: Number of adverse events in participants on Somatrogon
timeFrame: 3 years
Secondary outcomes:
measure: Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence
timeFrame: 3 years
Other outcomes:
Locations:
city: Chennai
country: India
facility: Apollo Children's Hospital
state: Tamil NADU
city: Coimbatore
country: India
facility: G Kuppuswamy Naidu Memorial Hospital
state: Tamil NADU
city: Madurai
country: India
facility: Apollo Speciality Hospital
state: Tamil NADU
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: