Evidence map›Paper›PMID 39513569›Full record

Trial reportClinical endocrinology2025

A Phase 2 Study of PEGylated Recombinant Human Growth Hormone for 52 Weeks in Short Children Born Small for Gestational Age in China.

Xiaoping Luo, Ling Hou, Yan Zhong, Sha Zhao, Xiaobo Chen, Qian Dong, Hongwei Du, Honghua Lu, Yu Yang, Xian Wu and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical endocrinology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02375620 (A Multicenter, Randomized, Open-Label, Dose-Response, Phase II Clinical Study of Pegylated Somatropin), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02375620 phase2active not recruitingnot on this map

A Multicenter, Randomized, Open-Label, Dose-Response, Phase II Clinical Study of Pegylated Somatropin (PEG Somatropin) Injection to Treat SGA Children With Short Stature.

TypeinterventionalSponsorChangchun GeneScience Pharmaceutical Co., Ltd.Ran2015 to 2025Enrolled96ConditionsShort Stature Children Born Small for Gestational Age (SGA)ArmsPEG-somatropin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Xiaoping LuoDepartment of Pediatrics, Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology, Wuhan, China.ORCID https://orcid.org/0000-0002-3748-4817
Ling HouDepartment of Pediatrics, Tongji Hospital, Tongji Medical School, Huazhong University of Science and Technology, Wuhan, China.
Yan ZhongDepartment of Child Health Care, Hunan Children's Hospital, Hunan, China.
Sha ZhaoDepartment of Child Health Care, Hunan Children's Hospital, Hunan, China.
Xiaobo ChenDepartment of Endocrinology, Children's Hospital, Capital Institute of Pediatrics, Beijing, China.
Qian DongDepartment of Endocrinology, Children's Hospital, Capital Institute of Pediatrics, Beijing, China.
Hongwei DuDepartment of Paediatrics, The First Hospital of Jilin University, Jilin, China.
Honghua LuDepartment of Paediatrics, The First Hospital of Jilin University, Jilin, China.
Yu YangDepartment of Endocrinology and Genetics, Jiangxi Provincial Children's Hospital, Jiangxi, China.
Xian WuDepartment of Endocrinology and Genetics, Jiangxi Provincial Children's Hospital, Jiangxi, China.
Feihong LuoDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China.
Ruoqian ChenDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China.
Zhuangjian XuDepartment of Pediatrics, Wuxi Fourth People's Hospital, Affiliated Hospital of Jiangnan University, Jiangsu, China.
Yaping MaDepartment of Pediatrics, Wuxi Fourth People's Hospital, Affiliated Hospital of Jiangnan University, Jiangsu, China.
Wenhui SongDepartment of Endocrinology, Children's Hospital of Shanxi, Women's Health Center of Shanxi, Shanxi, China.
Mei FengDepartment of Endocrinology, Children's Hospital of Shanxi, Women's Health Center of Shanxi, Shanxi, China.
Xuefan GuDepartment of Pediatric Endocrinology and Genetics, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Wenjuan QiuDepartment of Pediatric Endocrinology and Genetics, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Funding

This study was supported by GeneScience Pharmaceuticals.
6 · The paper itself

Abstract

objectiveChildren 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.

designIn 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.

resultsAt Week 52, the change in HT-SDS in the high- and low-dose groups was 0.923 ± 0.352 (p < 0.0001) and 0.511 ± 0.336 (p < 0.0001), respectively (least-squares means difference, 0.410; 95% confidence interval 0.270-0.551; p < 0.0001). Height velocity (9.94 ± 1.55 vs. 8.37 ± 1.50 cm/year) was also significantly higher in the high-dose than in the low-dose group (p < 0.0001). Change in insulin-like growth factor (IGF)-1 SDS was 1.867 ± 1.747 and 1.168 ± 1.193 in the high- and low-dose groups, respectively (p = 0.0189). IGF-1/IGF binding protein-3 and bone maturity were improved in both groups at Week 52. Most treatment-emergent adverse events were mild to moderate; the safety profile was similar in both groups.

conclusionsPEG-rhGH at either dose for 52 weeks was effective and well tolerated in children born SGA. Patients in the high-dose group achieved greater improvement in HT-SDS than in the low-dose group.

trial registrationClinicalTrials. gov identifier: NCT02375620.

Indexed as

Human Growth HormoneInfant, Small for Gestational AgeBody HeightChildChinaFemaleHumansInfant, NewbornInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IMalePolyethylene GlycolsRecombinant ProteinsHuman Growth HormoneInsulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IPolyethylene GlycolsRecombinant Proteinsefficacyheight standard deviation scoreheight velocitylong actingPEG‐rhGHsafetySGA

Identifiers

PMID39513569
PMCPMC11694553

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.