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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Completed; Phase 2

Conditions: Small for Gestational Age Infant

Treatments: Biological: Somatropin Injection high dose group; Biological: Somatropin Injection low dose group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03221933

GenSci 030 CT-II

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 24 to 90 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Somatropin Injection low dose group

Experimental group

Description:

0.23mg/kg /wk，inject for seven divided doses.

Treatment:

Biological: Somatropin Injection high dose group

Biological: Somatropin Injection low dose group

Somatropin Injection high dose group

Experimental group

Description:

0.46mg/kg /wk，inject for seven divided doses.

Treatment:

Biological: Somatropin Injection high dose group

Biological: Somatropin Injection low dose group