{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T22:44:26Z","timestamp":1790376266203,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,11,8]],"date-time":"2024-11-08T00:00:00Z","timestamp":1731024000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>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\u2010recombinant human growth hormone (PEG\u2010rhGH) in these children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>In this multicentre, randomised, open\u2010label, Phase 2 trial conducted at nine clinical sites in China, patients were randomised 1:1 to receive subcutaneous injections of PEG\u2010rhGH at 0.1\u2009mg\/kg\/week (low dose) or 0.2\u2009mg\/kg\/week (high dose) for 52 weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients<\/jats:title><jats:p>Ninety\u2010six children were born SGA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements<\/jats:title><jats:p>The primary endpoint was the change in height standard deviation score (HT\u2010SDS) at Week 52.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At Week 52, the change in HT\u2010SDS in the high\u2010 and low\u2010dose groups was 0.923\u2009\u00b1\u20090.352 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) and 0.511\u2009\u00b1\u20090.336 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001), respectively (least\u2010squares means difference, 0.410; 95% confidence interval 0.270\u20130.551; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). Height velocity (9.94\u2009\u00b1\u20091.55 vs. 8.37\u2009\u00b1\u20091.50\u2009cm\/year) was also significantly higher in the high\u2010dose than in the low\u2010dose group (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). Change in insulin\u2010like growth factor (IGF)\u20101 SDS was 1.867\u2009\u00b1\u20091.747 and 1.168\u2009\u00b1\u20091.193 in the high\u2010 and low\u2010dose groups, respectively (<jats:italic>p<\/jats:italic>\u2009=\u20090.0189). IGF\u20101\/IGF binding protein\u20103 and bone maturity were improved in both groups at Week 52. Most treatment\u2010emergent adverse events were mild to moderate; the safety profile was similar in both groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>PEG\u2010rhGH at either dose for 52 weeks was effective and well tolerated in children born SGA. Patients in the high\u2010dose group achieved greater improvement in HT\u2010SDS than in the low\u2010dose group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials. gov identifier: NCT02375620<\/jats:p><\/jats:sec>","DOI":"10.1111\/cen.15156","type":"journal-article","created":{"date-parts":[[2024,11,8]],"date-time":"2024-11-08T12:43:08Z","timestamp":1731069788000},"page":"136-146","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A Phase 2 Study of PEGylated Recombinant Human Growth Hormone for 52 Weeks in Short Children Born Small for Gestational Age in China"],"prefix":"10.1111","volume":"102","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3748-4817","authenticated-orcid":false,"given":"Xiaoping","family":"Luo","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Tongji Hospital, Tongji Medical School Huazhong University of Science and Technology Wuhan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Hou","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Tongji Hospital, Tongji Medical School Huazhong University of Science and Technology Wuhan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Zhong","sequence":"additional","affiliation":[{"name":"Department of Child Health Care Hunan Children's Hospital  Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sha","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Child Health Care Hunan Children's Hospital  Hunan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaobo","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Children's Hospital Capital Institute of Pediatrics Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Dong","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Children's Hospital Capital Institute of Pediatrics Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongwei","family":"Du","sequence":"additional","affiliation":[{"name":"Department of Paediatrics The First Hospital of Jilin University Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Honghua","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Paediatrics The First Hospital of Jilin University Jilin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Genetics Jiangxi Provincial Children's Hospital  Jiangxi 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