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A Phase 2 Study of PEGylated Recombinant Human Growth Hormone for 52 Weeks in Short Children Born Small for Gestational Age in China
ABSTRACT Objective Children born small for gestational age (SGA) are at increased risk of health issues. This study evaluated the efficacy, safety and optimal dose of PEGylated‐recombinant human growth hormone (PEG‐rhGH) in these children. Design In this multicentre, randomised, open‐label, Phase 2...
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Published in: | Clinical endocrinology (Oxford) 2025-02, Vol.102 (2), p.136-146 |
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Main Authors: | , , , , , , , , , , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites |
Online Access: | Get full text |
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Summary: | ABSTRACT
Objective
Children born small for gestational age (SGA) are at increased risk of health issues. This study evaluated the efficacy, safety and optimal dose of PEGylated‐recombinant human growth hormone (PEG‐rhGH) in these children.
Design
In this multicentre, randomised, open‐label, Phase 2 trial conducted at nine clinical sites in China, patients were randomised 1:1 to receive subcutaneous injections of PEG‐rhGH at 0.1 mg/kg/week (low dose) or 0.2 mg/kg/week (high dose) for 52 weeks.
Patients
Ninety‐six children were born SGA.
Measurements
The primary endpoint was the change in height standard deviation score (HT‐SDS) at Week 52.
Results
At Week 52, the change in HT‐SDS in the high‐ and low‐dose groups was 0.923 ± 0.352 (p |
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ISSN: | 0300-0664 1365-2265 1365-2265 |
DOI: | 10.1111/cen.15156 |