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

• 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

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2014-12
• Status Verified: 2017-07
• Study First Submitted: 2017-07-16
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Last Update Submitted: 2017-12-10
• Last Update Posted: 2017-12-12

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

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)
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
ΔHtSDSCA	26 weeks， 52 weeks，78 weeks and 104 weeks	Change in height SDS for chronological age (Ht SDSCA)

Trial Locations

Locations (5)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

The first affiliated Hospital with Nanjing Medical Universit; 🇨🇳 Nanjing, Jiangsu, China

Children's Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Children's Hospital of Capital Medical University; 🇨🇳 Beijing, China

Shanghai Children's Hospital; 🇨🇳 Shanghai, China