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The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature

21 juli 2026 bijgewerkt door: Xiamen Amoytop Biotech Co., Ltd.

Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection Versus Givopegsomatropin Solution Injection in the Treatment of Short Stature in Children With Turner Syndrome.

This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled. Stratified by age and karyotype, subjects will be randomized at a 1:1 ratio to either the test group or the positive control group with continuous treatment for 52 weeks. The study aims to compare the efficacy and safety of Inpegsomatropin-Injection versus Givopegsomatropin Solution Injection in children with TS-related short stature, so as to provide evidence for the new indication application of the investigational drug.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

84

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
      • Anyang, China
        • Werving
        • Anyang Maternal and Child Health Hospital
        • Contact:
          • Huiping An
      • Beijing, China
        • Werving
        • Peking University First Hospital
        • Contact:
          • Yanling Yang
      • Beijing, China
        • Werving
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
          • Di Wu
      • Beijing, China
        • Werving
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Hui Pan
      • Beijing, China
        • Werving
        • Capital Institute of Pediatrics, Capital Medical University
        • Contact:
          • Bingyan Cao
      • Changsha, China
        • Werving
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Xingxing Zhang
      • Chengdu, China
        • Werving
        • Chengdu Women's and Children's Central Hospital
        • Contact:
          • Xinran Cheng
      • Chongqing, China
        • Werving
        • Children's Hospital of Chongqing Medical University
        • Contact:
          • Min Zhu
      • Dalian, China
        • Werving
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Luyi Ma
      • Guangzhou, China
        • Werving
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
          • Liyang Liang
      • Guangzhou, China
        • Werving
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Qiuli Chen
      • Guangzhou, China
        • Werving
        • The third affiliated hospital of Sun Yat-Sen University
        • Contact:
          • Shunye Zhu
      • Guangzhou, China
        • Nog niet aan het werven
        • Guangdong Provincial Maternal and Child Health Hospital
        • Contact:
          • Shu Liu
      • Hangzhou, China
        • Werving
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Chunlin Wang
      • Hangzhou, China
        • Werving
        • Zhejiang Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Lan Li
      • Hebei, China
        • Werving
        • The First Affiliated Hospital of Hebei North University
        • Contact:
          • Zhengrong Xu
      • Henan, China
        • Werving
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Dan Lou
      • Huzhou, China
        • Werving
        • Huzhou Central Hospital
        • Contact:
          • Wei Qiu
      • Jiangxi, China
        • Werving
        • Jiangxi Provincial Children's Hospital
        • Contact:
          • Yu Yang
      • Jilin City, China
        • Werving
        • The First Hospital of Jilin University
        • Contact:
          • Yining Zhang
      • Jinan, China
        • Werving
        • Shandong Provincial Hospital
        • Contact:
          • Yan Sun
      • Jining, China
        • Werving
        • Affiliated Hospital of Jining Medical University
        • Contact:
          • Mei Zhang
      • Kunming, China
        • Werving
        • Kunming Children's Hospital
        • Contact:
          • Na Tao
      • Lanzhou, China
        • Werving
        • Gansu Provincial People's Hospital
        • Contact:
          • Juxiang Liu
      • Nanning, China
        • Werving
        • The Second Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Xin Fan
      • Pingxiang, China
        • Werving
        • Pingxiang People's Hospital
        • Contact:
          • Guangping Qin
      • Qilu, China
        • Werving
        • Qilu Hospital of Shandong University
        • Contact:
          • Aihua Cao
      • Shanghai, China
        • Werving
        • Shanghai Children's Hospital
        • Contact:
          • Fei Wang
      • Shanghai, China
        • Werving
        • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Wenjuan Qiu
      • Shanghai, China
        • Werving
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Wenli Lu
      • Shanghai, China
        • Werving
        • Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Yu Ding
      • Shanxi, China
        • Werving
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • Contact:
          • Haibo Lin
      • Shaoxing, China
        • Werving
        • Shaoxing people's Hospital
        • Contact:
          • Dihua Huang
      • Shenyang, China
        • Werving
        • Shengjing Hospital of China Medical University
        • Contact:
          • Ying Xin
      • Shenzhen, China
        • Werving
        • Shenzhen Children's Hospital
        • Contact:
          • Zhe Su
      • Sichuan, China
        • Werving
        • West China Second University Hospital, Sichuan University
        • Contact:
          • Jin Wu
      • Suzhou, China
        • Werving
        • Children's Hospital of Soochow University
        • Contact:
          • Fengyun Wang
      • Taizhou, China
        • Werving
        • Taizhou People's Hospital
        • Contact:
          • Shufang Yang
      • Taizhou, China
        • Werving
        • Taizhou First People's Hospital
        • Contact:
          • Xiaoming Ying
      • Tangshan, China
        • Werving
        • Tangshan Maternal and Child Health Hospital
        • Contact:
          • Lanying Wang
      • Wenzhou, China
        • Werving
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hong Zhu
      • Wuhan, China
        • Werving
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaoping Luo
      • Wuhan, China
        • Werving
        • Wuhan Children's Hospital
        • Contact:
          • Hui Yao
      • Wuxi, China
        • Werving
        • Affiliated Hospital of Jiangnan University
        • Contact:
          • Yaping Ma
      • Xi'an, China
        • Werving
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Erdi Xu
      • Xiamen, China
        • Nog niet aan het werven
        • Xiamen Maternal and Child Health Hospital
        • Contact:
          • Xiaoqing Yang
      • Xiangyang, China
        • Werving
        • Xiangyang First People's Hospital
        • Contact:
          • Xi Yang
      • Xinjiang, China
        • Werving
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Mirigul Maimaiti
      • Yibin, China
        • Werving
        • Yibin Second People's Hospital
        • Contact:
          • Lan Yao
      • Zhengzhou, China
        • Werving
        • Henan Children's Hospital Zhengzhou Children's Hospital
        • Contact:
          • Haiyan Wei
      • Zibo, China
        • Werving
        • Zibo Central Hospital
        • Contact:
          • Xiaodong Zhao

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Prepubertal girls at Tanner stage I, with age ≥ 2 years and < 12 years at the time of informed consent signature.
  • With clinical manifestations of Turner syndrome and a confirmed diagnosis of Turner syndrome based on peripheral blood karyotype analysis (karyotype analysis of at least 30 metaphase cells).
  • At screening, bone age is delayed relative to chronological age or advanced by no more than 1 year (i.e., bone age - chronological age ≤ 1 year).
  • At screening, height is below -2 standard deviations (-2SD) of the mean for age and gender; height reference is shown in Appendix 1.
  • No prior systematic pharmacological growth-promoting treatment (continuous use for ≥ 1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.
  • Thyroid hormone replacement therapy (if applicable) received prior to randomization should be maintained on a stable regimen for at least 4 weeks.
  • The legal guardian understands and signs the informed consent form; participants aged ≥ 8 years shall also sign the informed consent form. For participants aged under 8 years who are capable of expressing assent, their assent shall be clearly documented.

Exclusion Criteria:

  • Subjects with closed epiphyses.
  • Patients with Turner syndrome carrying Y chromosome or Y-chromosome-derived fragments and without gonadectomy.
  • Other types of growth and development abnormalities, including but not limited to growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, and growth retardation caused by malnutrition.
  • Participation in any other clinical trial within 3 months prior to screening with pharmacological or non-pharmacological intervention received.
  • Inhaled glucocorticoids used continuously for more than 2 weeks, or oral/intravenous glucocorticoids used continuously for more than 1 week within 3 months prior to screening.
  • Receiving other treatments that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, etc.
  • Abnormal liver and renal function at screening (ALT > 2 times the upper limit of normal; Cr > upper limit of normal).
  • Subjects with abnormal glucose metabolism, including: a. Diagnosed diabetes mellitus; b. Fasting blood glucose ≥ 6.1 mmol/L on two consecutive measurements; c. Glycated hemoglobin (HbA1c) ≥ 6.5%; d. Impaired glucose tolerance judged by the investigator as unsuitable for participation in this study.
  • Presence of chronic infectious diseases judged by the investigator to interfere with study participation, such as chronic hepatitis B.
  • Subjects with systemic chronic diseases, such as chronic kidney disease, severe cardiovascular diseases (e.g., aortic dissection, uncontrolled hypertension), psychiatric and psychological disorders.
  • Subjects with severe congenital skeletal dysplasia; or those with scoliosis > 20°, significant kyphosis, claudication, or a prior diagnosis of slipped capital femoral epiphysis.
  • Subjects with a prior history of intracranial hypertension.
  • Subjects with a history of malignant tumor or current active malignant tumor, including intracranial tumors.
  • Known hypersensitivity to growth hormone or its excipients.
  • Subjects with celiac disease who have not maintained a gluten-free diet within 12 months prior to screening.
  • Any other conditions deemed inappropriate for enrollment in this clinical trial by the investigator.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Inpegsomatropin Injection Group
Geneesmiddel: Inpegsomatropin-Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Actieve vergelijker: Givopegsomatropin Solution Injection Group
Geneesmiddel: Givopegsomatropin Solution Injection
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
GROEISE SELECHEID (HV, CM/JAAR).
Tijdsspanne: Week 52
Week 52

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Verandering in hoogte Standaardafwijkingsscore van de basislijn (△ HT SDS)
Tijdsspanne: Van basislijn tot alle follow-up tijdstippen op week 52
Van basislijn tot alle follow-up tijdstippen op week 52
Verandering in insuline-achtige groeifactor 1 Standaardafwijkingsscore van de basislijn (△ IGF-1 SDS)
Tijdsspanne: Van basislijn tot alle follow-up tijdstippen op week 52
Van basislijn tot alle follow-up tijdstippen op week 52
Change in height velocity from baseline (△HV)
Tijdsspanne: From baseline to all follow-up time points at Week 52
From baseline to all follow-up time points at Week 52
Ratio of change in bone age from baseline to change in chronological age from baseline (△BA/△CA)
Tijdsspanne: Week 52
Week 52

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Onderzoekers

  • Hoofdonderzoeker: Xiaoping Luo, Tongji Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 juli 2026

Primaire voltooiing (Geschat)

30 maart 2028

Studie voltooiing (Geschat)

28 februari 2030

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PEGPESEN-4-2-004

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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