Learning about Somatrogon for treating growth hormone deficiency in children in India
Official title: A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
Run by Pfizer · NCT06587035 · Data updated 2026-11-12
This study is testing the safety of a new growth hormone injection called Somatrogon in children with growth hormone deficiency in India.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 4 sites (Bengaluru, Karnataka and 3 other locations) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | September 21, 2026 |
| Study ends | September 5, 2028 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT06587035 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 3 years or older who have been diagnosed with pediatric growth hormone deficiency and are prescribed Somatrogon.
✕Probably not a fit
Patients currently participating in other interventional clinical trials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety of Somatrogon, an injection used to treat pediatric growth hormone deficiency (p GHD) in children aged 3 years and older in India. Participants will be those diagnosed with p GHD who are prescribed Somatrogon, and the study will monitor any side effects experienced over a period of three years. The information gathered will help understand the safety profile of Somatrogon in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of Somatrogon, potentially improving treatment options for children with growth hormone deficiency.
How similar studies have gone: While this study focuses on the safety of Somatrogon, similar studies assessing growth hormone treatments have shown promising results, indicating a potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
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
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.