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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Unknown; Phase 3

Conditions: Small for Gestational Age Infant

Treatments: Drug: Recombinant Human Growth Hormone Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03245333

GenSci 030 CT-III

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 24 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Stage 1-experimental group

Experimental group

Description:

JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）, for 52 weeks.

Treatment:

Drug: Recombinant Human Growth Hormone Injection

Drug: Recombinant Human Growth Hormone Injection

Stage 1-negative control

Other group

Description:

observed only for 52 weeks.

Treatment:

Drug: Recombinant Human Growth Hormone Injection

Drug: Recombinant Human Growth Hormone Injection

Stage 2-experimental group

Experimental group

Description:

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.

Treatment:

Drug: Recombinant Human Growth Hormone Injection

Drug: Recombinant Human Growth Hormone Injection

Stage 2-negative control

Other group

Description:

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.

Treatment:

Drug: Recombinant Human Growth Hormone Injection

Drug: Recombinant Human Growth Hormone Injection