A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA

Small for Gestational Age Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221933
• Other study ID #: GenSci 030 CT-II
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2017
• Last updated: December 10, 2017
• Start date: December 2009

Study information

• Verified date: July 2017
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 90 Months

Eligibility

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.

Related Conditions & MeSH terms

• Small for Gestational Age Infant

Intervention

Biological:
• Somatropin Injection low dose group
0.23mg/kg /wk,inject for seven divided doses
• Somatropin Injection high dose group
0.46mg/kg /wk,inject for seven divided dose

Locations

Country	Name	City	State
China	Beijing Children's Hospital of Capital Medical University	Beijing
China	Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The first affiliated Hospital with Nanjing Medical Universit	Nanjing	Jiangsu
China	Shanghai Children's Hospital	Shanghai
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (6)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Beijing Children's Hospital, Shanghai Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, The First Affiliated Hospital with Nanjing Medical University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height standard deviation score for chronological age (Ht SDSCA)	HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)	26 weeks
Primary	Height standard deviation score for chronological age (Ht SDSCA)	HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)	52 weeks
Primary	Height standard deviation score for chronological age (Ht SDSCA)	HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)	78 weeks
Primary	Height standard deviation score for chronological age (Ht SDSCA)	HtSDSCA = (height-reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint)	104 weeks
Secondary	?HtSDSCA	Change in height SDS for chronological age (Ht SDSCA)	26 weeks, 52 weeks,78 weeks and 104 weeks
Secondary	Change in HV	Change in annualized height velocity (HV)	26 weeks, 52 weeks,78 weeks and 104 weeks
Secondary	Change in bone age maturation		26 weeks, 52 weeks,78 weeks and 104 weeks
Secondary	Change in mole ratio of IGF-1 and IGFBP-3		26 weeks, 52 weeks,78 weeks and 104 weeks
Secondary	Change in PAH	Change in prediction of adult height (PAH)	26 weeks, 52 weeks,78 weeks and 104 weeks
Secondary	Change in obesity prevalence		26 weeks, 52 weeks,78 weeks and 104 weeks
Secondary	Change in overweight		26 weeks, 52 weeks,78 weeks and 104 weeks