A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
Phase 3
- Conditions
- Small for Gestational Age Infant
- Interventions
- Registration Number
- NCT03245333
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1-experimental group Recombinant Human Growth Hormone Injection JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks. Stage 1-negative control Recombinant Human Growth Hormone Injection observed only for 52 weeks. Stage 2-experimental group Recombinant Human Growth Hormone Injection 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. Stage 2-negative control Recombinant Human Growth Hormone Injection 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.
- Primary Outcome Measures
Name Time Method Change of height standard deviation score for chronological age (△Ht SDSCA) 52 weeks △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 )
- Secondary Outcome Measures
Name Time Method Height（Ht）at the end of treatment Stage 2：Every 52 weeks, up to 3 years Annualized height velocity (HV) Stage 2：Every 52 weeks, up to 3 years Bone age maturation Stage 2：Every 52 weeks, up to 3 years Mole ratio of IGF-1 and IGFBP-3 Stage 2：Every 52 weeks, up to 3 years IGF-1 standard deviation score (SDS) Stage 2：Every 52 weeks, up to 3 years
Trial Locations
- Locations (5)
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Shanghai Children's Hospital
🇨🇳Shanghai, 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