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

28. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

84

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Inpegsomatropin Injection Group
Medicin: Inpegsomatropin-Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Aktiv komparator: Givopegsomatropin Solution Injection Group
Medicin: Givopegsomatropin Solution Injection
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Væksthastighed (HV, CM/år).
Tidsramme: Uge 52
Uge 52

Sekundære resultatmål

Resultatmål
Tidsramme
Ændring i højde standardafvigelsesscore fra baseline (△ ht SDS)
Tidsramme: Fra baseline til alle opfølgende tidspunkter i uge 52
Fra baseline til alle opfølgende tidspunkter i uge 52
Ændring i insulinlignende vækstfaktor 1 Standardafvigelsesscore fra baseline (△ IGF-1 SDS)
Tidsramme: Fra baseline til alle opfølgende tidspunkter i uge 52
Fra baseline til alle opfølgende tidspunkter i uge 52
Change in height velocity from baseline (△HV)
Tidsramme: 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)
Tidsramme: Week 52
Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Efterforskere

  • Ledende efterforsker: Xiaoping Luo, Tongji Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

30. marts 2028

Studieafslutning (Anslået)

28. februar 2030

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PEGPESEN-4-2-004

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Turners syndrom

Kliniske forsøg med Inpegsomatropin-Injection

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