Phase Ⅱ Clinical Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for Gestational Age(SGA)

Changchun GeneScience Pharmaceutical Co., Ltd.5 sites in 1 country120 target enrollmentDecember 2009

ConditionsSmall for Gestational Age Infant

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Small for Gestational Age Infant
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Enrollment: 120
Locations: 5
Primary Endpoint: Height standard deviation score for chronological age (Ht SDSCA)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

December 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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+
•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.

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.

Outcomes

Primary Outcomes

Height standard deviation score for chronological age (Ht SDSCA)

Time Frame: 104 weeks

HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)

Secondary Outcomes

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 bone age maturation(26 weeks， 52 weeks，78 weeks and 104 weeks)
Change in PAH(26 weeks， 52 weeks，78 weeks and 104 weeks)
Change in HV(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)
ΔHtSDSCA(26 weeks， 52 weeks，78 weeks and 104 weeks)