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

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

According to the results of the phase II study, choose the best dose of JINTOPIN AQ for short SGA children, further to evaluate the efficacy and safety of the treatment of short SGA children.

Study Overview

• Status: Unknown
• Conditions: Small for Gestational Age Infant
• Intervention / Treatment: Drug: Recombinant Human Growth Hormone Injection; Drug: Recombinant Human Growth Hormone Injection

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiaoping Luo; Phone Number: +86-27-83663712; Email: xpluo@tjh.tjmu.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of full-term 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).
• 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 participating in the study.
• Bone age<Chronological age+1.
• Normal glucose regulation：Fasting blood-glucose < 5.6mmol/L, and 2 hours postprandial blood-glucose < 7.8mmol/L.
• Gestational age was 37 to 42 weeks.
• The subjects and their guardians signed informed consent.

Exclusion Criteria:

• Subjects with Liver and renal insufficiency (ALT > 1.5 times of upper limit of normal value, Cr> upper limit of normal value).
• Patients are positive for antibodies to hepatitis B core (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 growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome and growth hormone receptor deficiency.
• Subjects who have received the treatment of GH.
• Subjects took part in other clinical trial study within 3 months.
• Children who have treated with other hormone (such as gonadal hormone and glucocorticoids etc, continuous administration of more than a month) and that may affect growth hormone secretion or action including oxygen male dragon, growth hormone releasing hormone, etc. 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: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1-experimental group; JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.	Drug: Recombinant Human Growth Hormone Injection; Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.; Other Names: rhGH Injection; Drug: Recombinant Human Growth Hormone Injection; Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.; Other Names: rhGH Injection
Other: Stage 1-negative control; observed only for 52 weeks.	Drug: Recombinant Human Growth Hormone Injection; Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.; Other Names: rhGH Injection; Drug: Recombinant Human Growth Hormone Injection; Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.; Other Names: rhGH Injection
Experimental: Stage 2-experimental group; After completing the stage 1, experimental groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.	Drug: Recombinant Human Growth Hormone Injection; Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.; Other Names: rhGH Injection; Drug: Recombinant Human Growth Hormone Injection; Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.; Other Names: rhGH Injection
Other: Stage 2-negative control; After completing the stage 1, negative control groups is administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd week to the final height.	Drug: Recombinant Human Growth Hormone Injection; Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.; Other Names: rhGH Injection; Drug: Recombinant Human Growth Hormone Injection; Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.; Other Names: rhGH Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of height standard deviation score for chronological age (△Ht SDSCA)	△Ht SDS= Ht SDSafter treatment - Ht SDSbaseline Ht SDSCA = (height - reference mean for CA) / reference SD for CA (refers to the height value at particular timepoint )	52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Height（Ht）at the end of treatment	Stage 1：52 weeks
Height（Ht）at the end of treatment	Stage 2：Every 52 weeks, up to 3 years
Annualized height velocity (HV)	Stage 1：52 weeks
Annualized height velocity (HV)	Stage 2：Every 52 weeks, up to 3 years
Bone age maturation	Stage 1：52 weeks
Bone age maturation	Stage 2：Every 52 weeks, up to 3 years
Mole ratio of IGF-1 and IGFBP-3	Stage 1：52 weeks
Mole ratio of IGF-1 and IGFBP-3	Stage 2：Every 52 weeks, up to 3 years
IGF-1 standard deviation score (SDS)	Stage 1：52 weeks
IGF-1 standard deviation score (SDS)	Stage 2：Every 52 weeks, up to 3 years

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, 2014
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 10, 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

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: GenSci 030 CT-III

Drug and device information, study documents

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