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

Capital Medical University

Status

Enrolling

Conditions

Growth Disorders

Growth Hormone Treatment

Treatments

Drug: Polyethylene glycol recombinant human growth hormone injection

Study type

Observational

Funder types

Other

Identifiers

NCT06037473

Gensci-LAGH-23003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

2,600 estimated patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

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;

Trial design

2,600 participants in 5 patient groups

growth hormone deficiency(GHD)

Description:

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

Treatment:

Drug: Polyethylene glycol recombinant human growth hormone injection

Idiopathic short stature (ISS)

Description:

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.

Treatment:

Drug: Polyethylene glycol recombinant human growth hormone injection

small for gestational age (SGA)

Description:

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

Treatment:

Drug: Polyethylene glycol recombinant human growth hormone injection

Turner Syndrome (TS)

Description:

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

Treatment:

Drug: Polyethylene glycol recombinant human growth hormone injection