Clinical trial: Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I) (NCT02380235)

Eligibility criteria:
Inclusion Criteria:

          -  Before starting treatment, according to the medical history, clinical symptoms and
             signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.

               -  According to the height statistical data of Chinese children's physique
                  development in nine cities in 2005,height is lower than the third percentile of
                  growth curve of normal children with the same age and gender.

               -  Height velocity (HV) ≤5.0 cm/yr.

               -  GH stimulation test with two different mechanisms affirms that GH peak
                  concentration of patients' plasma<10.0ng/ml.

               -  Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than
                  his/her chronological age (CA).

          -  Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.

          -  Receive no prior GH treatment within 6 months.

          -  Sign informed consent.

        Exclusion Criteria:

          -  People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal
             value, Cr> the upper limit of normal value).

          -  Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen
             (HBsAg) or hepatitis Be antigen (HBeAg).

          -  People with known highly allergic constitution or allergy to the drug of the study.

          -  People with severe cardiopulmonary, hematological and malignant tumors diseases or
             general infection and immune deficiency.

          -  Diabetic.

          -  Potential tumor patients (family history).

          -  Abnormal growth and development, such as Turner syndrome, constitutional delay of
             growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth
             retardation without excluding abnormal chromosome.

          -  Subjects took part in other clinical trial study within 3 months.

          -  Other conditions which in the opinion of the investigator preclude 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? Contradiction