Clinical trial: Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency (NCT02908958)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 18 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Entailment