Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

GeneScience Pharmaceuticals (GenSci)

Status and phase: Unknown; Phase 4

Conditions: Growth Hormone Deficiency

Treatments: Biological: PEG-somatropin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02908958

GenSci 004 CT-Zhejiang

Details and patient eligibility

About

To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

Enrollment: 900 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
• According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
• Height velocity (HV) ≤5.0 cm/yr.
• GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
• Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
• Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
• The child did not receive the treatment of growth hormone within 6 months.
• Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.

Exclusion criteria

• The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
• The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
• The child is known as hypersensitivity to PEG Somatropin.
• The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
• The child has potential tumor (family history).
• The child has diabetics.
• The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
• The child took part in other clinical trials within 3 months.
• Other conditions are excluded when the investigator preclude the enrollment into the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

900 participants in 2 patient groups

PEG-somatropin

Experimental group

Description:

Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.

Treatment:

Biological: PEG-somatropin

Biological: PEG-somatropin

PEG-Somatropin

Experimental group

Description:

High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.

Treatment:

Biological: PEG-somatropin

Biological: PEG-somatropin