Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 900
• Participant gender: Both

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Central South University; First Affiliated Hospital of Guangxi Medical University; First People's Hospital of Hangzhou; Guangzhou Women and Children's Medical Center; Qilu Hospital; Second Affiliated Hospital of Wenzhou Medical University; Shanghai Children's Medical Center; Shaoxing Second Hospital; Southwest Hospital, China; The Children's Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Xiamen University; The Second Hospital of Anhui Medical University; Third Affiliated Hospital, Sun Yat-Sen University; Xiangya Hospital of Central South University; Zhejiang Provincial Hospital of TCM; Zhejiang Provincial People’s Hospital
• Treatments: Hormones
• Last Updated: 2016-09-20

Criteria

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.