The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorBeijing Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Polyethylene glycol recombinant human growth hormone injection
Drug0.1-0.3mg/kg.w
Treatment groups
2,600 Participants
are divided into 5 treatment groupsGroup A: growth hormone deficiency(GHD)1 intervention
Group B: Idiopathic short stature (ISS)1 intervention
Group C: small for gestational age (SGA)1 intervention
Group D: Turner Syndrome (TS)1 intervention
Group E: others1 intervention
Trial outcomes
Primary outcomes
1
the change in height standard deviation score
final adult height standard deviation score- height standard deviation score before treatment
Time frame
3-10yearsSponsors and contacts
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Beijing Children's Hospital
Lead sponsor
University of Glasgow
Collaborator
Source ClinicalTrials.gov