A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
NCT ID: NCT03221933
Last Updated: 2017-12-12
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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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2009-12-31
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
SINGLE
Study Groups
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Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses.
Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses
Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided dose
Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided doses.
Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses
Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided dose
Interventions
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Somatropin Injection low dose group
0.23mg/kg /wk，inject for seven divided doses
Somatropin Injection high dose group
0.46mg/kg /wk，inject for seven divided dose
Eligibility Criteria
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Inclusion Criteria
* Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
* Prepubertal stage (Tanner I).
* Without catch-up growth in two years after birth.
* Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
* A GH peak concentration \>10µg/L in a provocative test within a year before participate in the study.
* Bone age\<Chronological age+1.
* Normal glucose regulation：Fasting blood-glucose \< 5.6mmol/L and 2-hour postprandial blood glucose\< 7.8mmol/L.
* Gestational age≥Gestational age≥ 36weeks + 4days.
* Never accepted growth hormone treatment.
* The subjects and their guardians signed informed consent.
Exclusion Criteria
* Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
* Known highly allergic constitution or allergic to the test drug.
* Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
* Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
* Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
24 Months
90 Months
ALL
No
Sponsors
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Tongji Hospital
OTHER
Beijing Children's Hospital
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
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 affiliated Hospital with Nanjing Medical Universit
Nanjing, Jiangsu, China
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Children's Hospital of Capital Medical University
Beijing, , China
Shanghai Children's Hospital
Shanghai, , China
Countries
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Other Identifiers
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GenSci 030 CT-II
Identifier Type: -
Identifier Source: org_study_id