NCT06587035

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

StatusRecruiting

PhaseNot specified

SponsorPfizer

Primary completionSep 5, 2028 (estimated)

At risk: Primary completion moved at least 1 year 11 months later.

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Record History

All 23 versions: 11 with changes below, 12 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 10, 2026 Primary completion pushed from Sep 21, 2026 to Sep 5, 2028
Notable Sep 23, 2026 Eligibility criteria expanded, about 3 words
- Site details revised at 1 of 4 sites
Minor Jan 6, 2026 Study sites: 3 to 4v16
Minor Sep 17, 2025 Study completion date: Dec 24, 2026 to Sep 5, 2028v14
Minor May 23, 2025 Study sites: 2 to 3v9

Show 5 earlier versionsHide 5 earlier versions

Notable Mar 13, 2025 Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 2
- Start date changed from estimate of Feb 2025 to Jan 30, 2025
v7
Minor Feb 20, 2025 Start date: Feb 5, 2025 to Feb 2025v6
Notable Jan 6, 2025 Enrollment target: 100 to 50
- Start date: Dec 2024 to Feb 5, 2025
- Study completion date: Sep 21, 2026 to Dec 24, 2026
v4
Notable Dec 16, 2024 Start date: Oct 28, 2024 to Dec 2024v3
Notable Oct 7, 2024 Start date: Sep 20, 2024 to Oct 28, 2024
- Primary completion date: Apr 15, 2026 to Sep 21, 2026
v2

Sep 4, 2024 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Number of adverse events in participants on Somatrogon

Timeframe: 3 years

Secondary (1)

Number of participants reporting missed injections with Somatrogon in order to evaluate treatment adherence

Arms and interventions

Patients of pediatric growth hormone deficiency

Drugs: Somatrogon

Sites

4 sites in 1 country

About this trial

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.

Trial details

Enrollment: 50 participants (estimated)
Started: Jan 30, 2025
Study completion: Sep 5, 2028 (estimated)
Eligibility: 3 to 17, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee, FDA-regulated drug
Conditions: Dwarfism, Pituitary
Official title: A Multicenter, Non-interventional Prospective Active Surveillance Study Among Participants Receiving Somatrogon Under Routine Clinical Care in India
First posted: Sep 19, 2024
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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