Clinical trial NCT03221933: A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
Official title: Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 2017-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 24
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Height standard deviation score for chronological age (Ht SDSCA)
timeFrame: 26 weeks
measure: Height standard deviation score for chronological age (Ht SDSCA)
timeFrame: 52 weeks
measure: Height standard deviation score for chronological age (Ht SDSCA)
timeFrame: 78 weeks
measure: Height standard deviation score for chronological age (Ht SDSCA)
timeFrame: 104 weeks
Secondary outcomes:
measure: ΔHtSDSCA
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
measure: Change in HV
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
measure: Change in bone age maturation
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
measure: Change in mole ratio of IGF-1 and IGFBP-3
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
measure: Change in PAH
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
measure: Change in obesity prevalence
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
measure: Change in overweight
timeFrame: 26 weeks， 52 weeks，78 weeks and 104 weeks
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 Universit
state: Jiangsu
city: Hangzhou
country: China
facility: Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing Children's Hospital of Capital Medical University
city: Shanghai
country: China
facility: Shanghai Children's Hospital
Study officials:
affiliation: Department of Pediatrics of Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Xiaoping Luo
role: PRINCIPAL_INVESTIGATOR
References: