Evidence map›Paper›PMID 34899612›Full record

Trial reportFrontiers in endocrinology2021

Reduced Effectiveness and Comparable Safety in Biweekly

Chengjun Sun, Biao Lu, Yu Liu, Yaqin Zhang, Haiyan Wei, Xu Hu, Pei Hu, Qian Zhao, Yanling Liu, Kan Ye and 17 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Frontiers in endocrinology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02976675 (Pegylated Somatropin), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.5field-weighted citation impact, top 17% 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.

NCT02976675 phase4unknown statusnot on this map

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin

TypeinterventionalSponsorChangchun GeneScience Pharmaceutical Co., Ltd.Ran2015Enrolled600ConditionsGrowth Hormone DeficiencyArmsPEG-somatropin
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Observational
  8. [Early diagnosis and intervention for prepubertal short stature children].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2024
    Review
  9. Article
  10. Article
  11. First Clinical Study on Long-Acting Growth Hormone Therapy in Children with Turner Sydrome.Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2022
    Article
  12. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 1 country.

Chengjun SunDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China.
Biao LuDepartment of Pediatrics, General Hospital of Ningxia Medical University, Yinchuan, China.
Yu LiuDepartment of Endocrine and Genetic Metabolism, Maternal and Child Health-Care Hospital in Guiyang, Guiyang, China.
Yaqin ZhangDepartment of Child Health, Maternal and Child Health Care Hospital of Hainan Province, Haikou, China.
Haiyan WeiDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Henan Provincial Hospital, Affiliated to Zhengzhou University, Zhengzhou, China.
Xu HuDepartment of Pediatrics, Lu'an People's Hospital, Lu'an, China.
Pei HuClinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, National Medical Products Administration (NMPA) Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical Pharmacokinetics and Pharmacodynamics (PK & PD) Investigation for Innovative Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Qian ZhaoClinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, National Medical Products Administration (NMPA) Key Laboratory for Clinical Research and Evaluation of Drug, Beijing Key Laboratory of Clinical Pharmacokinetics and Pharmacodynamics (PK & PD) Investigation for Innovative Drugs, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Yanling LiuDepartment of Pediatrics, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Kan YeDepartment of Child Health, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, China.
Kan WangDepartment of Pediatrics, Jinhua Hospital, Zhejiang University School of Medicine, Jinhua, China.
Zaiyan GuDepartment of Pediatrics, Jiaxing First Hospital, Jiaxing, China.
Zheng LiuDepartment of Pediatrics, Tai'an Maternal and Child Health Care Hospital, Tai'an, China.
Jin YeDepartment of Pediatrics, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
Hongxiao ZhangDepartment of Pediatrics, Second Hospital of Lanzhou University, Lanzhou, China.
Hong ZhuDepartment of Pediatrics, The First People's Hospital of Changzhou, Changzhou, China.
Zhihong JiangDepartment of Pediatrics, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Yanjie LiuDepartment of Pediatrics, Inner Mongolia People's Hospital, Hohhot, China.
Naijun WanDepartment of Pediatrics, Jishuitan Hospital, Beijing, China.
Chengming YanDepartment of Pediatrics, Anhui Province Maternity and Child Health Hospital, Anhui Medical University Maternal and Child Health Clinic College, Hefei, China.
Jianying YinDepartment of Pediatrics, Hebei General Hospital, Shijiazhuang, China.
Lirong YingDepartment of Pediatrics, Cixi People's Hospital, Cixi, China.
Feng HuangDepartment of Pediatrics, Affiliated Hospital of Nantong University, Nantong, China.
Qingjin YinDepartment of Internal Medicine, Chengdu Children's Specialized Hospital, Chengdu, China.
Li XiDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China.
Feihong LuoDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China.
Ruoqian ChengDepartment of Pediatric Endocrinology and Inherited Metabolic Diseases, Children's Hospital of Fudan University, Shanghai, China.
Children's Hospital of Fudan University · CNNational Medical Products Administration · CNSecond Affiliated Hospital of Nanchang University · CNAffiliated Hospital of Nantong University · CNAnhui Medical University · CNBeijing Jishuitan Hospital · CNChengdu Women's and Children's Central Hospital · CNCixian People's Hospital · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNFirst Hospital of Jiaxing · CNHainan Maternal and Child Health Hospital · CNHebei General Hospital · CNJiangsu Province Hospital · CNLanzhou University Second Hospital · CNLu'an First People's Hospital · CNNanchang University · CNNanjing Medical University · CNNingxia Medical University · CNTaiyuan Maternity and Child Care Hospital · CNThe First People's Hospital of Changzhou · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Context: Long-acting recombinant human growth hormone (rhGH) has transformed growth hormone deficiency (GHD) treatment. However, the possibility and rationality for flexible time regimen are pending. Objective: We studied the efficacy of biweekly Design Setting and Patients: This multicenter, phase IV trial with a non-inferiority threshold ≥20% enrolled 585 Tanner stage I GHD children. Intervention: Subjects randomly received 0.20 mg/kg once-weekly or biweekly PEG-rhGH, or 0.25 mg/kg.w rhGH once daily for 26 weeks. Main Outcome Measure: The primary outcome was height SD scores for chronological age (HtSDS Results: At week 26, the median HtSDS Conclusions: Although notably promoted height velocity, biweekly PEG-rhGH failed the non-inferiority threshold as compared with either weekly PEG-rhGH or daily rhGH. Compared with short-term rhGH, long-acting PEG-rhGH did not significantly increase tumor-associated IGF-2 and IGFBP-2 expressions. Clinical Trial Registration: clinicaltrials.gov, identifier NCT02976675.

Indexed as

ChildChild, PreschoolChinaDrug Administration ScheduleDwarfism, PituitaryEquivalence Trials as TopicFemaleGrowth DisordersHuman Growth HormoneHumansMalePolyethylene GlycolsRecombinant ProteinsTreatment OutcomeHuman Growth HormonePolyethylene GlycolsRecombinant Proteinschildrengrowth hormone deficiencyIGF-2PEG-rhGHPEGylated recombinant human growth hormone

Identifiers

PMID34899612
PMCPMC8655095
OpenAlexW3215479879

What OpenQuestion holds

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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.