Clinical trial NCT03245333: A Study of Recombinant Human Growth Hormone Injection for Short Children With Small for Small for Gestational Age(SGA)
Official title: Phase Ⅲ Clinical Study of Recombinant Human Growth Hormone Injection (JINTOPIN AQ) for Short Children With Small for Gestational Age(SGA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Small for Gestational Age Infant
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tongji Hospital
name: Beijing Children's Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Shanghai Children's Hospital
name: The Children's Hospital of Zhejiang University School of Medicine
First posted: 2017-08-10
Enrollment: 120
Sex: ALL
Minimum age (years): 24
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of height standard deviation score for chronological age (△Ht SDSCA)
timeFrame: 52 weeks
Secondary outcomes:
measure: Height（Ht）at the end of treatment
timeFrame: Stage 1：52 weeks
measure: Height（Ht）at the end of treatment
timeFrame: Stage 2：Every 52 weeks, up to 3 years
measure: Annualized height velocity (HV)
timeFrame: Stage 1：52 weeks
measure: Annualized height velocity (HV)
timeFrame: Stage 2：Every 52 weeks, up to 3 years
measure: Bone age maturation
timeFrame: Stage 1：52 weeks
measure: Bone age maturation
timeFrame: Stage 2：Every 52 weeks, up to 3 years
measure: Mole ratio of IGF-1 and IGFBP-3
timeFrame: Stage 1：52 weeks
measure: Mole ratio of IGF-1 and IGFBP-3
timeFrame: Stage 2：Every 52 weeks, up to 3 years
measure: IGF-1 standard deviation score (SDS)
timeFrame: Stage 1：52 weeks
measure: IGF-1 standard deviation score (SDS)
timeFrame: Stage 2：Every 52 weeks, up to 3 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: The first affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Hangzhou
country: China
facility: The Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
city: Shanghai
country: China
facility: Shanghai Children's Hospital
Study officials:
References: