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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
Main Authors: Luo, Xiaoping, Hou, Ling, Zhong, Yan, Zhao, Sha, Chen, Xiaobo, Dong, Qian, Du, Hongwei, Lu, Honghua, Yang, Yu, Wu, Xian, Luo, Feihong, Chen, Ruoqian, Xu, Zhuangjian, Ma, Yaping, Song, Wenhui, Feng, Mei, Gu, Xuefan, Qiu, Wenjuan
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Language:English
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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 
ISSN:0300-0664
1365-2265
1365-2265
DOI:10.1111/cen.15156