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| Name | Class |
|---|---|
| Children's Hospital of Fudan University | OTHER |
| Tongji Hospital | OTHER |
| Children's Hospital of Nanjing Medical University | OTHER |
| Jiangxi Province Children's Hospital |
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To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant human growth hormone | Experimental | Recombinant human growth hormone Injection (15IU/5mg/3ml/bottle)ï¼›0.05 mg/kg/d by subcutaneous injection for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human growth hormone | Drug | Recombinant human growth hormone (15IU/5mg/3ml/bottle)，0.05 mg/kg/d by subcutaneous injection for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Annualized Height Velocity (AHV) at Week 52 | The change in AHV after 52 weeks treatment | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AHV | Change in AHV at week, week 13, week 26, week 39 | week 4, week 13, week 26, week 39 |
| Change From Baseline in Height Standard Deviation Score (Ht SDS) | Change From Baseline in Ht SDS at week 4, week 13, week 26, week 39, week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Metabolism-related Proteins | Change From Baseline in Serum Proteomics at week 13, week 26, week 52 | week 13, week 26, week 52 |
Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanru Wu | Contact | +86 15843110489 | wuyanru@gensci-china.com |
| Name | Affiliation | Role |
|---|---|---|
| Feihong Luo | Children's Hospital of Fudan University | Principal Investigator |
| Xiaoping Luo | Tongji Hospital | Principal Investigator |
| Wei Gu |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
Drugs belong to the sponsor before they are put into clinical trials and the site is only a contract research organization; It is an industry practice that intellectual property rights belong to the sponsor.
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| ID | Term |
|---|---|
| D000130 | Achondroplasia |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| OTHER |
| Chengdu Women's and Children's Central Hospital | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Shengjing Hospital | OTHER |
| Shanghai Children's Hospital | OTHER |
| Children's Hospital of The Capital Institute of Pediatrics | OTHER |
| West China Second University Hospital | OTHER |
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| week 4, week 13, week 26, week 39, week 52 |
| Change From Baseline in BMI Standard Deviation Score (BMI SDS) | Change From Baseline in BMI SDS at week 4, week 13, week 26, week 39, week 52 | week 4, week 13, week 26, week 39, week 52 |
| Change From Baseline in Sitting Height/Leg Length ratio Standard Deviation Score (SH/LL SDS) | Change From Baseline in SH/LL SDS at week 4, week 13, week 26, week 39, week 52 | week 4, week 13, week 26, week 39, week 52 |
| Change From Baseline in IGF-1 Standard Deviation Score (IGF -1 SDS) | Change From Baseline in IGF-1 SDS at week 4, week 13, week 26, week 39, week 52 | week 4, week 13, week 26, week 39, week 52 |
| Change From Baseline in IGF-1/IGFBP-3 ratio | Change From Baseline in IGF-1/IGFBP-3 ratio at week 4, week 13, week 26, week 39, week 52 | week 4, week 13, week 26, week 39, week 52 |
| Change From Baseline in Bone Age/Chronological Age ratio (BA/CA) | Change From Baseline in BA/CA at week 52 | week 52 |
| Children's Hospital of Nanjing Medical University |
| Principal Investigator |
| Yu Yang | Jiangxi Province Children's Hospital | Principal Investigator |
| Xinran Cheng | Chengdu Women's and Children's Central Hospital | Principal Investigator |
| Guimei Li | Shandong Provincial Hospital | Principal Investigator |
| Ying Xin | Shengjing Hospital of China Medical Hospital | Principal Investigator |
| Pin Li | Shanghai Children's Hospital | Principal Investigator |
| Xiaobo Chen | Children's Hospital of The Capital Institute of Pediatrics | Principal Investigator |
| Jin Wu | West China Second University Hospital | Principal Investigator |
| D010009 |
| Osteochondrodysplasias |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |