A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
NCT ID: NCT03245333
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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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2014-12-31
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
NONE
Study Groups
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Stage 1-experimental group
JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.
Recombinant Human Growth Hormone Injection
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Recombinant Human Growth Hormone Injection
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-negative control
observed only for 52 weeks.
Recombinant Human Growth Hormone Injection
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Recombinant Human Growth Hormone Injection
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 2-experimental group
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.
Recombinant Human Growth Hormone Injection
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Recombinant Human Growth Hormone Injection
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 2-negative control
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.
Recombinant Human Growth Hormone Injection
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Recombinant Human Growth Hormone Injection
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.
Interventions
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Recombinant Human Growth Hormone Injection
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Recombinant Human Growth Hormone Injection
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.
Other Intervention Names
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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).
* 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 participating in the study.
* Bone age\<Chronological age+1.
* Normal glucose regulation：Fasting blood-glucose \< 5.6mmol/L, and 2 hours postprandial blood-glucose \< 7.8mmol/L.
* Gestational age was 37 to 42 weeks.
* The subjects and their guardians signed informed consent.
Exclusion Criteria
* Patients are positive for antibodies to hepatitis B core (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 growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.
* Subjects who have received the treatment of GH.
* Subjects took part in other clinical trial study within 3 months.
* Children who have treated with other hormone (such as gonadal hormone and glucocorticoids etc, continuous administration of more than a month) and that may affect growth hormone secretion or action including oxygen male dragon, growth hormone releasing hormone, etc. within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
24 Years
90 Years
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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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 University
Nanjing, Jiangsu, China
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Beijing Children's Hospital, Capital Medical University
Beijing, , China
Shanghai Children's Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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GenSci 030 CT-III
Identifier Type: -
Identifier Source: org_study_id