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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
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To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)).
To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection and titration for future clinical development and clinical application in these population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YPEG-GH low dose group | Experimental |
| |
| YPEG-GH high dose group | Experimental |
| |
| rhGH low dose group | Active Comparator |
| |
| rhGH high dose group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YPEG-rhGH | Drug | YPEG-rhGH, 140μg/kg, s.c., once a week, for 52 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic-area under plasma concentration versus time curve | up to 52 weeks | |
| Pharmacokinetic-maximum serum concentration | up to 52weeks | |
| Pharmacokinetic-time to reach the maximum plasma concentration | up to 52 weeks | |
| Pharmacokinetic-terminal disposition phase half-life | up to 52 weeks | |
| Pharmacokinetic-terminal elimination rate constant | up to 52 weeks | |
| Pharmacokinetic-apparent clearance after extravascular administration | up to 52 weeks | |
| Pharmacokinetic-apparent volume of distribution | up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics-the properties of Insulin-like growth facto1 and Insulin-like growth factor binding receptor 3. | up to 57 weeks | |
| Height velocity (HV, cm/year) | At 52 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| The Second Hospital of Anhui Medical University |
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| ID | Term |
|---|---|
| D014424 | Turner Syndrome |
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| YPEG-rhGH |
| Drug |
YPEG-rhGH, 280μg/kg, s.c., once a week, for 52 weeks |
|
| rhGH | Drug | rhGH, 245μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks |
|
| rhGH | Drug | rhGH, 470μg/kg/week, divided into 7 subcutaneous injections, once daily, for 52 weeks |
|
| Change of height velocity compared to baseline (ΔHV, cm/year) |
| At 52 weeks of treatment |
| Height standard deviation according to chronological age (Ht SDS CA) | At 52 weeks of treatment |
| Change in bone age | At 52 weeks of treatment |
| Adverse events (including injection site reactions), changes from baseline in vital signs and laboratory tests | up to 57 weeks |
| Hefei |
| Anhui |
| China |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Sanya Central Hospital (Hainan Third People's Hospital) | Sanya | Hainan | China |
| Henan Children's Hospital Zhengzhou Children's Hospital | Zhengzhou | Henan | China |
| Tongji Hospital, Tongji Medical College of HUST | Wuhan | Hubei | China |
| Wuhan Children's Hospital | Wuhan | Hubei | China |
| Hunan Children's Hospital | Changsha | Hunan | China |
| Children's Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| Children's Hospital of Soochow University | Suzhou | Jiangsu | China |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
| Jiangxi Provincial Children's Hospital | Nanchang | Jiangxi | China |
| Chengdu Women's and Children's Central Hospital | Chengdu | Sichuan | China |
| West China Second University Hospital, Sichuan University | Chengdu | Sichuan | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| Children's Hospital, Capital Institute of Pediatrics | Beijing | China |
| Children's Hospital of Shanghai | 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 |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |