Learning about Somatrogon for treating growth hormone deficiency in children in India
A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 4 sites (Bengaluru, Karnataka and 3 other locations) |
| Trial ID | NCT06587035 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients currently participating in other interventional clinical trials may not benefit from this study.
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 performed: While this study focuses on the safety of Somatrogon, similar studies assessing growth hormone treatments have shown promising results, indicating a potential for success.
Eligibility criteria
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 this trial is running
Bengaluru, Karnataka and 3 other locations
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.