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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| Beijing Children's Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Shanghai Children's Hospital |
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According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1-experimental group | Experimental | JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks. |
|
| Stage 1-negative control | Other | observed only for 52 weeks. |
|
| Stage 2-experimental group | Experimental | After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height. |
|
| Stage 2-negative control | Other | After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Growth Hormone Injection | Drug | Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of height standard deviation score for chronological age (△Ht SDSCA) | △Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint ) | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Height（Ht）at the end of treatment | Stage 1：52 weeks | |
| Height（Ht）at the end of treatment | Stage 2：Every 52 weeks, up to 3 years | |
| Annualized height velocity (HV) |
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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 | |
| Xiaoping Luo | Contact | +86-27-83663712 | xpluo@tjh.tjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
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|
| Recombinant Human Growth Hormone Injection | Drug | Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height. |
|
|
| Stage 1：52 weeks |
| Annualized height velocity (HV) | Stage 2：Every 52 weeks, up to 3 years |
| Bone age maturation | Stage 1：52 weeks |
| Bone age maturation | Stage 2：Every 52 weeks, up to 3 years |
| Mole ratio of IGF-1 and IGFBP-3 | Stage 1：52 weeks |
| Mole ratio of IGF-1 and IGFBP-3 | Stage 2：Every 52 weeks, up to 3 years |
| IGF-1 standard deviation score (SDS) | Stage 1：52 weeks |
| IGF-1 standard deviation score (SDS) | Stage 2：Every 52 weeks, up to 3 years |
| The first affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 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 |
| Shanghai Children's Hospital | Recruiting | Shanghai | China |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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