A Study of PEG-somatropin in the Treatment of Children With Idiopathic Short Stature
NCT ID: NCT03221088
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
360 participants
INTERVENTIONAL
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Jintrolong® low dose group
PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
Jintrolong® low dose group
PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Jintrolong® high dose group
PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Jintrolong® high dose group
PEG-rhGH Injection (27IU/4.5mg/0.5ml/bottle) 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
Jintrolong® low dose group
PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Jintrolong® high dose group
PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Negative control group
Untreated Control Group
No interventions assigned to this group
Interventions
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Jintrolong® low dose group
PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Jintrolong® high dose group
PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Height \<-2 SD for chronological age.
* Growth velocity\<5.0 cm/yr.
* GH peak concentration ≥10.0 ng/mL in two different stimulation tests.
* The difference of bone age (BA) and chronological age (CA) is within -2 to +2.
* IGF-1 concentration is between -2 SDS to +2 SDS.
* Prepubertal Status(Tanner Stage I).
* Birth weight within the normal range.
* Growth hormone treatment-naive.
* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion Criteria
* Subjects are positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
* Subjects with known highly allergic constitution or allergy to investigational product or its excipient.
* Subjects with systemic chronic disease and immune deficiency.
* Patients diagnosed with tumor.
* Patients with mental disease.
* Patients with other types of abnormal growth and development.
1. Growth hormone deficiency (GHD) (confirmed by GH stimulation test);
2. Turner syndrome (confirmed by karyotype test of girls);
3. Noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (PTPN11) gene on chromosome 12 for half of the patients, for both male and female patients);
4. Laron sydrome (confirmed by IGF-1 generation test);
5. Small for gestational age ( the birth height or weight is below the tenth percentile or 2 SD, with catch-up growth uncompleted at 2 years old).
* Growth disorders caused by malnutrition or hypothyroidism (thyroid function test).
* Congenital skeletal abnormalities or scoliosis, claudication.
* Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes).
* Subjects with abnormal electrolyte, blood gas analysis (vein), creatine kinase.
* Subjects who took part in other clinical trials within 3 months.
* Subjects who received medications which may interfere GH secretion or GH function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.).
* For patients with potential high tumor risks such as tumor markers exceed normal range and some other relative information, they may be excluded from the treatment.
* Other conditions which is inappropriate for this study in the opinion of the investigator.
4 Years
9 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
The First Hospital of Jilin University
OTHER
Affiliated Hospital of Jiangnan University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Shanghai Children's Hospital
OTHER
The Children's Hospital of Zhejiang University School of Medicine
OTHER
Children's Hospital of Fudan University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoping Luo
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Locations
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Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 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
Countries
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Central Contacts
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Facility Contacts
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Xiaoping Luo, PhD
Role: primary
Yuhua Hu, MD
Role: primary
Zhuangjian Xu, MD
Role: primary
Hongwei Du, MD
Role: primary
Junfen Fu, MD
Role: primary
Feihong Luo, MD
Role: primary
Pin Li, MD
Role: primary
Other Identifiers
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GenSci 033 CT-one year
Identifier Type: -
Identifier Source: org_study_id
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