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| Name | Class |
|---|---|
| Beijing Children's Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Shanghai Children's Hospital | OTHER |
| Children's Hospital of Fudan University |
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This study aims to explore the optimal dose of pegylated recombinant human growth hormone (PEG-rhGH) injection to treat children of Turner syndrome (TS), preliminarily evaluate its safety and efficacy and provide scientific and reliable evidence for the medication dosage in Phase 3 clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhGH low dose | Experimental | PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks. |
|
| PEG-rhGH high dose | Experimental | PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks. |
|
| Non-treatment control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhGH low dose | Biological | PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of height standard deviation score before and after treatment (ΔHT SDS) | The change of height standard deviation score of chronological age before and after treatment | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Height Velocity | Annual growth rate at the end of treatment | 52 weeks |
| ΔBA/ΔCA | Bone maturation (changes of bone age/ chang of chronological age) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Feng | Contact | 0431-85170552 | fengxiaohua@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunxiu Gong, PhD | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D014424 | Turner Syndrome |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C562190 | polyethylene glycol-recombinant human growth hormone |
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| OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The First Hospital of Jilin University | OTHER |
| Jiangxi Province Children's Hospital | OTHER |
| Affiliated Hospital of Jiangnan University | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
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| PEG-rhGH high dose | Biological | PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks. |
|
|
| Non-treatment control group | Other |
|
| 52 weeks |
| IGF-1(Insulin-like growth factor 1) SDS | 52 weeks |
| Affiliated Hospital of Jiangnan University | Recruiting | Wuxi | Jiangsu | China |
|
| Jiangxi Provincial Children's Hospital | Recruiting | Nanchang | Jiangxi | China |
|
| First Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
|
| The Children's Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
|
| Beijing Children's Hospital,Capital Medical University | Recruiting | Beijing | China |
|
| Children's Hospital of Fudan University | Recruiting | Shanghai | China |
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| Shanghai Children's Hospital | Recruiting | Shanghai | China |
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| Xinhua Hospital of Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |