A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
Phase 2
Completed
- Conditions
- Small for Gestational Age Infant
- Interventions
- Biological: Somatropin Injection low dose groupBiological: Somatropin Injection high dose group
- Registration Number
- NCT03221933
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Somatropin Injection high dose group Somatropin Injection low dose group 0.46mg/kg /wk，inject for seven divided doses. Somatropin Injection high dose group Somatropin Injection high dose group 0.46mg/kg /wk，inject for seven divided doses. Somatropin Injection low dose group Somatropin Injection high dose group 0.23mg/kg /wk，inject for seven divided doses. Somatropin Injection low dose group Somatropin Injection low dose group 0.23mg/kg /wk，inject for seven divided doses.
- Primary Outcome Measures
Name Time Method Height standard deviation score for chronological age (Ht SDSCA) 104 weeks HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)
- Secondary Outcome Measures
Name Time Method Change in obesity prevalence 26 weeks， 52 weeks，78 weeks and 104 weeks Change in overweight 26 weeks， 52 weeks，78 weeks and 104 weeks Change in PAH 26 weeks， 52 weeks，78 weeks and 104 weeks Change in prediction of adult height (PAH)
ΔHtSDSCA 26 weeks， 52 weeks，78 weeks and 104 weeks Change in height SDS for chronological age (Ht SDSCA)
Change in HV 26 weeks， 52 weeks，78 weeks and 104 weeks Change in annualized height velocity (HV)
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
Trial Locations
- Locations (5)
Shanghai Children's Hospital
🇨🇳Shanghai, China
The first affiliated Hospital with Nanjing Medical Universit
🇨🇳Nanjing, Jiangsu, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Children's Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Children's Hospital of Capital Medical University
🇨🇳Beijing, China