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NCT Number: NCT06037473

The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg

In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after treatment, etc., collect and analyze more scientifically and rationally, and understand the situation of real-world PEG-GH treatment. A database registration study was developed.

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Key information

Conditions

Growth Hormone Treatment Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Endocrinology, Genetics, Metabolism

Beijing, Beijing Municipality, 010, China

Location status: Recruiting

Location contact

chunxiu Gong, doctor

CONTACT

[email protected]

13370115001 ext. 59616326

About this study

A database registration study was developed to retrospectively analyze the efficacy and safety of polyethylene glycol recombinant human growth hormone injection in the treatment of slow growth in children caused by endogenous growth hormone deficiency, idiopathic short stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order to participate in the global real-world use of long-acting growth hormone, all data from this study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and Bone Disorders (GloBE-Reg) platform.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection

Exclusion criteria

Patients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;

Treatment and study plan

Polyethylene glycol recombinant human growth hormone injection

Drug

0.1-0.3mg/kg.w

Primary outcomes

  1. the change in height standard deviation score

    Time frame: 3-10years

    final adult height standard deviation score- height standard deviation score before treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Chunxiu Gong, Dr.

CONTACT

[email protected]

13370115001

Jiajia Chen, Dr.

CONTACT

[email protected]

13810773718

Sponsors and collaborators

Lead sponsor

Beijing Children's Hospital

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

A Real-world Study of the Efficacy and Safety of PEGylated Recombinant Human Growth Hormone Injection in the Treatment of Short Stature in Chinese Children From the Global Registry for Novel Therapies For Rare Bone or Endocrine Conditions

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Sep 14, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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