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

NCT ID: NCT06037473

Last Updated: 2025-09-04

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

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Recruitment Status

RECRUITING

Total Enrollment

2600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2029-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Growth Hormone Treatment Growth Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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growth hormone deficiency(GHD)

Growth hormone deficiency (GHD) is a rare and treatable condition that causes short height in children and metabolic issues in adults.

Polyethylene glycol recombinant human growth hormone injection

Intervention Type DRUG

0.1-0.3mg/kg.w

Idiopathic short stature (ISS)

Idiopathic short stature is a condition in which the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population, in whom no identifiable disorder is present.

Polyethylene glycol recombinant human growth hormone injection

Intervention Type DRUG

0.1-0.3mg/kg.w

small for gestational age (SGA)

Small for gestational age (SGA) is defined as a birth weight of less than 10th percentile for gestational age.

Polyethylene glycol recombinant human growth hormone injection

Intervention Type DRUG

0.1-0.3mg/kg.w

Turner Syndrome (TS)

Turner syndrome, a condition that affects only females, results when one of the X chromosomes (sex chromosomes) is missing or partially missing.

Polyethylene glycol recombinant human growth hormone injection

Intervention Type DRUG

0.1-0.3mg/kg.w

others

others who with the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population.

Polyethylene glycol recombinant human growth hormone injection

Intervention Type DRUG

0.1-0.3mg/kg.w

Interventions

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Polyethylene glycol recombinant human growth hormone injection

0.1-0.3mg/kg.w

Intervention Type DRUG

Eligibility Criteria

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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;
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunxiu Gong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bingyan Cao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital

Locations

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Department of Endocrinology, Genetics, Metabolism

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunxiu Gong, Dr.

Role: CONTACT

13370115001

Jiajia Chen, Dr.

Role: CONTACT

13810773718

Facility Contacts

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chunxiu Gong, doctor

Role: primary

13370115001 ext. 59616326

Other Identifiers

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Gensci-LAGH-23003

Identifier Type: -

Identifier Source: org_study_id

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