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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

565 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2026-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ngenla Subcutaneous Injection Special Investigation

NCT05602766

Growth Hormone Deficiency Without Epiphyseal Closure

ACTIVE_NOT_RECRUITING

A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone

NCT06113952

Pediatric Growth Hormone Deficiency

WITHDRAWN

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

NCT03249480

Growth Hormone Deficiency

UNKNOWN PHASE4

Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

NCT00519844

Foetal Growth Problem Small for Gestational Age

COMPLETED PHASE4

Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

NCT04938466

Growth Hormone Deficiency Growth Hormone Treatment

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Growth Hormone Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants receiving Ngenla

Participants receiving Ngenla according to label

Ngenla

Intervention Type DRUG

As provided in real world practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ngenla

As provided in real world practice

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- 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.

Exclusion Criteria

1. Patients concurrently participating in other studies involving therapeutic interventions and/or investigational products;
2. Patients who have contraindications to somatrogon as specified in the approved LPD.
3. Patients with hypersensitivity or case history to somatrogon or to any of the excipients in the product

Minimum Eligible Age

3 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No