A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)
1 other identifier
interventional
120
1 country
5
Brief Summary
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 16, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedDecember 12, 2017
July 1, 2017
5 years
July 16, 2017
December 10, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
26 weeks
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
52 weeks
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
78 weeks
Height standard deviation score for chronological age (Ht SDSCA)
HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
104 weeks
Secondary Outcomes (7)
ΔHtSDSCA
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in HV
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in bone age maturation
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in mole ratio of IGF-1 and IGFBP-3
26 weeks， 52 weeks，78 weeks and 104 weeks
Change in PAH
26 weeks， 52 weeks，78 weeks and 104 weeks
- +2 more secondary outcomes
Study Arms (2)
Somatropin Injection low dose group
EXPERIMENTAL0.23mg/kg /wk，inject for seven divided doses.
Somatropin Injection high dose group
EXPERIMENTAL0.46mg/kg /wk，inject for seven divided doses.
Interventions
0.23mg/kg /wk，inject for seven divided doses
0.46mg/kg /wk，inject for seven divided dose
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of small for gestational age, SGA.
- 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.
You may not qualify if:
- Subjects with Liver and renal insufficiency (ALT \> 2 times of upper limit of normal value, Cr\> upper limit of normal value).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Tongji Hospitalcollaborator
- Beijing Children's Hospitalcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Shanghai Children's Hospitalcollaborator
- The Children's Hospital of Zhejiang University School of Medicinecollaborator
Study Sites (5)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoping Luo
Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2017
First Posted
July 19, 2017
Study Start
December 1, 2009
Primary Completion
December 1, 2014
Last Updated
December 12, 2017
Record last verified: 2017-07