Evidence map›Paper›PMID 36034448›Full record

Trial reportFrontiers in endocrinology2022

The pharmacokinetic and pharmacodynamic properties and short-term outcome of a novel once-weekly PEGylated recombinant human growth hormone for children with growth hormone deficiency.

Yan Liang, Cai Zhang, Haiyan Wei, Hongwei Du, Gaixiu Zhang, Yu Yang, Hua Zhang, Haihong Gong, Pin Li, Fuying Song and 6 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in endocrinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04513171 (A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% of its field
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.

NCT04513171 phase2 / phase3completednot on this map

A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.

TypeinterventionalSponsorXiamen Amoytop Biotech Co., Ltd.Ran2018 to 2023Enrolled434ConditionsGrowth Hormone DeficiencyArmsY-shape pegylated somatropin, Norditropin®, Norditropin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Review
  8. Insulin-like growth factor-1 (IGF-1) empowering tendon regenerative therapies.Frontiers in bioengineering and biotechnology · 2025
    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

16 authors at 11 institutions in 1 country.

Yan LiangDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Cai ZhangDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Haiyan WeiDepartment of Endocrinology, Genetics and Metabolism, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.
Hongwei DuDepartment of Pediatrics, The First Affiliated Hospital, Jilin University, Changchun, China.
Gaixiu ZhangDepartment of Pediatric Endocrinology, Shanxi Provincial Children's Hospital, Taiyuan, China.
Yu YangDepartment of Endocrinology, Genetics and Metabolism, Jiangxi Provincial Children's Hospital, Nanchang, China.
Hua ZhangDepartment of Pediatrics, Sanya Central Hospital, Sanya, China.
Haihong GongDepartment of Pediatrics, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Pin LiDepartment of Endocrinology, Children's Hospital of Shanghai, Shanghai Jiao Tong University, Shanghai, China.
Fuying SongDepartment of Endocrinology, Children's Hospital, Capital Institute of Pediatrics, Beijing, China.
Zhuangjian XuDepartment of Pediatrics, Wuxi Fourth People's Hospital, Wuxi, China.
Ruoyi HeOffice of General Manager, Xiamen Amoytop Biotech Co., Ltd, Xiamen, China.
Weidong ZhouOffice of General Manager, Xiamen Amoytop Biotech Co., Ltd, Xiamen, China.
Heng ZhengDepartment of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Li SunOffice of General Manager, Xiamen Amoytop Biotech Co., Ltd, Xiamen, China.
Xiaoping LuoDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Huazhong University of Science and Technology · CNTongji Hospital · CNChildren's Hospital of Capital Institute of Pediatrics · CNFirst Hospital of Jilin University · CNJiangsu Province Hospital · CNJiangxi Provincial Children's Hospital · CNSanya Central Hospital · CNShanghai Children's Hospital · CNShanxi Provincial Children's Hospital · CNWuxi Fourth People's Hospital · CNZhengzhou University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of Y-shape branched PEGylated recombinant human growth hormone (YPEG-rhGH) and evaluate its short-term efficacy and safety in children with growth hormone deficiency (GHD). Methods: A total of 43 children with GHD from 12 sites in China were enrolled in this randomized, multicenter, active-controlled, double-blind (YPEG-rhGH doses) trial. Patients were randomized 1:1:1:1 to 100, 120, and 140 μg/kg/week of YPEG-rhGH groups and daily rhGH 35 μg/kg/day groups. The treatment lasted 12 weeks. The primary outcome was the area under the curve of the change of insulin-like growth factor-1 (IGF-1). The secondary outcome was the height velocity (HV) increment at week 12. Results: A dose-dependent response of maximum plasma concentration (C Conclusion: The PK/PD suggests that YPEG-rhGH is suitable for the once-weekly treatment of pediatric GHD. YPEG-rhGH 120 ~ 140 μg/kg/week provides the closest HV increment with similar safety and tolerability compared to daily rhGH 35 μg/kg/day in children with GHD. Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT04513171].

Indexed as

Dwarfism, PituitaryHuman Growth HormoneChildHumansInsulin-Like Growth Factor IPolyethylene GlycolsRecombinant ProteinsHuman Growth HormoneInsulin-Like Growth Factor IPolyethylene GlycolsRecombinant Proteinsclinical trialgrowth hormone deficiencylong-acting growth hormoneprepubertal childrenY-shape branched PEGylation

Identifiers

PMID36034448
PMCPMC9405430
OpenAlexW4290805807

What OpenQuestion holds

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LicenceCC BY
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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.