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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| Affiliated Hospital of Jiangnan University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University |
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After the first stage (52 weeks) of Phase II clinical trial, Pegylated recombinant human growth hormone (PEG-rhGH) injection of appropriate dose in compliance with ISS clinical treatment strategy is used to treat children with ISS (Idiopathic Short Stature). The long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-somatropin | Experimental | After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for the high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-somatropin | Drug | After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of yearly height velocity (ΔHV) | Change of yearly height velocity before and after treatment. Yearly Height Velocity=12×(Height Yx - Height at Baseline)/(Date of Yx - Date of Baseline)(Yx refers to the height value at particular timepoint x) | Baseline，the end of 3-year addendum |
| Measure | Description | Time Frame |
|---|---|---|
| Standard deviation score of height at the actual age (ΔHT SDS) | Standard deviation score of height at the actual age. | Baseline，every 3 months，the end of 3-year addendum |
| Change fo Bone maturation |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who have taken the following medications within 2 months before entering the extension period study:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Luo | Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University, National Center for Children's Health | Beijing | Beijing Municipality | China | |||
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| OTHER |
| Shanghai Children's Hospital | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Children's Hospital of Fudan University | OTHER |
| Jiangxi Province Children's Hospital | OTHER |
| Hunan Children's Hospital | OTHER_GOV |
| Beijing Children's Hospital | OTHER |
| Children's Hospital of Soochow University | OTHER |
| Wuxi Women's & Children's Hospital | OTHER |
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Change fo Bone maturation before and after treatement (bone age/chronological age)
| Baseline，every 3 months，the end of 3-year addendum |
| Change of IGF-1 SDS (ΔIGF-1 SDS) | Change of IGF-1 SDS before and after treatement | Baseline，every 3 months，the end of 3-year addendum |
| Changes of standard deviation scores of body mass index (ΔBMI SDS) | Changes of standard deviation scores of body mass index | Baseline，every 3 months，the end of 3-year addendum |
| The yearly average dose of PEG-rhGH injection | Baseline，every 3 months，the end of 3-year addendum |
| Final height (FH) | Final height | Baseline，every 3 months，the end of 3-year addendum |
| The improvement of FH compared with the baseline predicted adult height (PAH) | Baseline，every 3 months，the end of 3-year addendum |
| Improvement of NAH (near adult height) | For subjects who reach NAH with treatment but fail to follow-ups before reaching FH, the improvement of NAH in comparison with the baseline PAH (predicted adult height) shall be evaluated | Baseline，every 3 months，the end of 3-year addendum |
| the improvement of PAH | For subjects who fail to reach NAH with treatment and fail to follow-ups before reaching FH, the improvement of PAH in comparison with the baseline PAH shall be evaluated | Baseline，every 3 months，the end of 3-year addendum |
| The changes of the scores evaluated by the Quality of Life Scale | Baseline，every 3 months，the end of 3-year addendum |
| The changes of lean body mass (LBM) (optional) | Baseline，every 3 months，the end of 3-year addendum |
| The changes of fat mass (torso) (FM) (optional) | Baseline，every 3 months，the end of 3-year addendum |
| The changes of the percentage of body fat (optional) | Baseline，every 3 months，the end of 3-year addendum |
| The changes of bone mineral density (BMD) (optional) | Baseline，every 3 months，the end of 3-year addendum |
| Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan |
| Wuhan |
| Hubei |
| China |
| Hunan Children's Hospital | Changsha | Hunan | China |
| Children's Hospital of Soochow University | Naning | Jiangsu | China |
| The First Affiated Hospital of Nanjing Medical Universit | Nanjing | Jiangsu | China |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
| Wuxi Children's Hospital | Wuxi | Jiangsu | China |
| Jiangxi Provincial Children's Hospital | Nanchang | Jiangxi | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| The Children's Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Shanghai Children's Hospital of Fudan University | Shanghai | China |
| Shanghai Children's Hospital | Shanghai | China |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
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