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A study to learn about Somatrogon in patients with pediatric growth hormone deficiency (p GHD) in India

A multicenter, non-interventional prospective active surveillance study among patients receiving Somatrogon under routine clinical care in India - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/12/078228
Enrollment
100
Registered
2024-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E230- Hypopituitarism

Interventions

Intervention1: Somatrogon 24 mg/1.2 mL solution for injection in pre-filled pen : Somatrogon 24 mg/1.2 mL solution for injection in pre-filled pen (Genryzon) administered once weekly by subcutaneous i

Sponsors

Pfizer Products India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Prescription of Somatrogon for p GHD in participants aged 3 years or more. 2. 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

Exclusion criteria: 1. Participation in any interventional clinical trials at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
To estimate incidence rates (IRs) of safety events of interest among participants on Somatrogon.Timepoint: Data will be collected at baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

Secondary

MeasureTime frame
To evaluate treatment adherence and compliance of SomatrogonTimepoint: Data will be collected at baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

Countries

India

Contacts

Public ContactDr Mukundraj Keny

Pfizer Products India Private Limited

mukundrajsatyaranjan.keny@pfizer.com9011168903

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026