A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
Phase Ⅲ 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
According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
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, 2014
CompletedFirst Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedDecember 12, 2017
July 1, 2017
3 years
July 18, 2017
December 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of height standard deviation score for chronological age (△Ht SDSCA)
△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )
52 weeks
Secondary Outcomes (10)
Height（Ht）at the end of treatment
Stage 1：52 weeks
Height（Ht）at the end of treatment
Stage 2：Every 52 weeks, up to 3 years
Annualized height velocity (HV)
Stage 1：52 weeks
Annualized height velocity (HV)
Stage 2：Every 52 weeks, up to 3 years
Bone age maturation
Stage 1：52 weeks
- +5 more secondary outcomes
Study Arms (4)
Stage 1-experimental group
EXPERIMENTALJINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.
Stage 1-negative control
OTHERobserved only for 52 weeks.
Stage 2-experimental group
EXPERIMENTALAfter 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.
Stage 2-negative control
OTHERAfter 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.
Interventions
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of full-term 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).
- 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.
You may not qualify if:
- Subjects with Liver and renal insufficiency (ALT \> 1.5 times of upper limit of normal value, Cr\> upper limit of normal value).
- 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.
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 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2017
First Posted
August 10, 2017
Study Start
December 1, 2014
Primary Completion
December 1, 2017
Last Updated
December 12, 2017
Record last verified: 2017-07