Pediatric Growth Hormone DeficiencyNCT05509894
Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
An observational study of Pediatric Growth Hormone Deficiency, run by Pfizer at 1 site in South Korea.
Trial summary
This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Pediatric Growth Hormone Deficiency
- What is being tested?
- Ngenla
- How many people
- 565 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2024to 23 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will be performed in patients who have received at least 1 dose of Ngenla® pre-filled pen injection for the following indications as per local product label. (Treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone)
Who may be able to join
- 1. Children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone who have received treatment with somotarogon or have been determined to start treatment with somatrogon according to the approved indications of the medicinal product;
- 2. Evidence of a personally signed and dated informed consent document indicating that the patient or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
Who cannot join
- Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products;
- Patients who have contraindications to somatrogon as specified in the approved LPD.
- Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Surveillance (PMS) Study for Ngenla Prefilled Pen in Pediatric Patients Who Have Endogenous Growth Failure Due to an Inadequate Secretion of Endogenous Growth Hormone in Korea
This non-interventional study will be performed by design of post-marketing surveillance (PMS) as an additional pharmacovigilance activity of the Risk Management Plan (RMP) for Ngenla® pre-filled pen injection, which is required by the Ministry of Food and Drug Safety (MFDS) according to the local regulation. This post-marketing surveillance will investigate the safety and effectiveness of Ngenla® pre-filled pen injection as the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone during 6 years under the setting of routine practice in Korea.
- Conditions
- Pediatric Growth Hormone Deficiency
- Being tested
- Ngenla
- Keywords
- Pediatric Growth Hormone Deficiency, Somatrogon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NgenlaDrug
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Ngenla | Participants receiving Ngenla according to label Receives: Drug: Ngenla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: up to 28 days after last dose
Secondary outcomes (3)
Change from baseline in Annualized Height Velocity in cm/year
Measured: baseline, up to 12 months
Change from baseline in Height Standard Deviation Score
Measured: baseline, up to 12 months
Change from baseline in Bone Maturation (BM)
Measured: baseline, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start20 Jun 2024
- Primary completion23 Sep 2026 (estimated)
- Study completion23 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 565 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509894
- Sponsor's protocol ID
- C0311016
- Status last verified
- Jan 2026
- First submitted
- 19 Aug 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.