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

21. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Inpegsomatropin Injection Group
Legemiddel: Inpegsomatropin-Injection
Inpegsomatropin injection, 280 μg/kg/week, s.c., once weekly, for 52 weeks.
Aktiv komparator: Givopegsomatropin Solution Injection Group
Legemiddel: Givopegsomatropin Solution Injection
Givopegsomatropin Solution Injection, 200 μg/kg/week, s.c., once weekly, for 52 weeks.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Veksthastighet (HV, CM/år).
Tidsramme: Uke 52
Uke 52

Sekundære resultatmål

Resultatmål
Tidsramme
Endring i høydestandardavviksscore fra baseline (△ Ht SDS)
Tidsramme: Fra baseline til alle oppfølgingstidspunkt i uke 52
Fra baseline til alle oppfølgingstidspunkt i uke 52
Endring i insulinlignende vekstfaktor 1 Standardavviksscore fra baseline (△ IGF-1 SDS)
Tidsramme: Fra baseline til alle oppfølgingstidspunkt i uke 52
Fra baseline til alle oppfølgingstidspunkt i uke 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Etterforskere

  • Hovedetterforsker: Xiaoping Luo, Tongji Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juli 2026

Primær fullføring (Antatt)

30. mars 2028

Studiet fullført (Antatt)

28. februar 2030

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

21. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PEGPESEN-4-2-004

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere