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RecruitingNCT06037473

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

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
2,600 (estimated)
Sponsor
Beijing Children's Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGPolyethylene glycol recombinant human growth hormone injection0.1-0.3mg/kg.w

Timeline

Start date
2023-08-01
Primary completion
2029-01-01
Completion
2029-08-01
First posted
2023-09-14
Last updated
2025-09-04

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06037473. Inclusion in this directory is not an endorsement.