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

Small for Gestational Age Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245333
• Other study ID #: GenSci 030 CT-III
• Status: Recruiting
• Phase: Phase 3
• First received: July 18, 2017
• Last updated: December 10, 2017
• Start date: December 2014

Study information

• Verified date: July 2017
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Xiaohua Feng
• Phone: 0431-85170552
• Email: fengxiaohua[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Small for Gestational Age Infant

Intervention

Drug:
• Recombinant Human Growth Hormone Injection
Stage 1:JINTOPIN AQ 0.2IU/kg/d(0.46mg/kg /wk)for 52 weeks.
• 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.

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing
China	The Children's Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The first affiliated Hospital with Nanjing Medical University	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	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	Height(Ht)at the end of treatment		Stage 1:52 weeks
Secondary	Height(Ht)at the end of treatment		Stage 2:Every 52 weeks, up to 3 years
Secondary	Annualized height velocity (HV)		Stage 1:52 weeks
Secondary	Annualized height velocity (HV)		Stage 2:Every 52 weeks, up to 3 years
Secondary	Bone age maturation		Stage 1:52 weeks
Secondary	Bone age maturation		Stage 2:Every 52 weeks, up to 3 years
Secondary	Mole ratio of IGF-1 and IGFBP-3		Stage 1:52 weeks
Secondary	Mole ratio of IGF-1 and IGFBP-3		Stage 2:Every 52 weeks, up to 3 years
Secondary	IGF-1 standard deviation score (SDS)		Stage 1:52 weeks
Secondary	IGF-1 standard deviation score (SDS)		Stage 2:Every 52 weeks, up to 3 years