Small for Gestational Age Infant
Conditions
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.
Interventions
Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
Sponsors
Tongji Hospital
Beijing Children's Hospital
The First Affiliated Hospital with Nanjing Medical University
Shanghai Children's Hospital
The Children's Hospital of Zhejiang University School of Medicine
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Height（Ht）at the end of treatment | Stage 1：52 weeks |
| Annualized height velocity (HV) | Stage 1：52 weeks |
| Bone age maturation | Stage 1：52 weeks |
| Mole ratio of IGF-1 and IGFBP-3 | Stage 1：52 weeks |
| IGF-1 standard deviation score (SDS) | Stage 1：52 weeks |
Countries
China
Contacts
Primary ContactXiaohua Feng
Backup ContactXiaoping Luo
Outcome results
None listed