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

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

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.

Study Overview

• Status: Completed
• Conditions: Small for Gestational Age Infant
• Intervention / Treatment: Biological: Somatropin Injection low dose group; Biological: Somatropin Injection high dose group

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Children's Hospital of Capital Medical University
  • Shanghai, China
    • Shanghai Children's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The First Affiliated Hospital with Nanjing Medical Universit
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Children's Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somatropin Injection low dose group; 0.23mg/kg /wk，inject for seven divided doses.	Biological: Somatropin Injection low dose group; 0.23mg/kg /wk，inject for seven divided doses; Biological: Somatropin Injection high dose group; 0.46mg/kg /wk，inject for seven divided dose
Experimental: Somatropin Injection high dose group; 0.46mg/kg /wk，inject for seven divided doses.	Biological: Somatropin Injection low dose group; 0.23mg/kg /wk，inject for seven divided doses; Biological: Somatropin Injection high dose group; 0.46mg/kg /wk，inject for seven divided dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ΔHtSDSCA	Change in height SDS for chronological age (Ht SDSCA)	26 weeks， 52 weeks，78 weeks and 104 weeks
Change in HV	Change in annualized height velocity (HV)	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 mole ratio of IGF-1 and IGFBP-3		26 weeks， 52 weeks，78 weeks and 104 weeks
Change in PAH	Change in prediction of adult height (PAH)	26 weeks， 52 weeks，78 weeks and 104 weeks
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 16, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: GenSci 030 CT-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No