NCT06037473

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,600

participants targeted

Target at P75+ for all trials

Timeline
39mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Aug 2023Aug 2029

Study Start

First participant enrolled

August 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

5.4 years

First QC Date

August 15, 2023

Last Update Submit

August 28, 2025

Conditions

Growth Hormone TreatmentGrowth Disorders

Outcome Measures

Primary Outcomes (1)

  • the change in height standard deviation score

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

    3-10years

Study Arms (5)

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.

Drug: Polyethylene glycol recombinant human growth hormone injection

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.

Drug: Polyethylene glycol recombinant human growth hormone injection

small for gestational age (SGA)

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

Drug: Polyethylene glycol recombinant human growth hormone injection

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.

Drug: Polyethylene glycol recombinant human growth hormone injection

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.

Drug: Polyethylene glycol recombinant human growth hormone injection

Interventions

Polyethylene glycol recombinant human growth hormone injectionDRUG

0.1-0.3mg/kg.w

Idiopathic short stature (ISS)Turner Syndrome (TS)growth hormone deficiency(GHD)otherssmall for gestational age (SGA)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The height of the patients was below 2 stadard deviation below average. The patients were diagosesed as endogenous growth hormone deficiency, TS, SGA, ISS, etc. and treated with polyethylene glycol recombinant human growth hormone injection

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Genetics, Metabolism

Beijing, Beijing Municipality, 010, China

RECRUITING

MeSH Terms

Conditions

Growth Disorders

Interventions

polyethylene glycol-recombinant human growth hormone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bingyan Cao, Dr.

    Beijing Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunxiu Gong, Dr.

CONTACT

13370115001chunxiugong@163.com

Jiajia Chen, Dr.

CONTACT

13810773718chenjiaj2009@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 15, 2023

First Posted

September 14, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations

CN(1)