Clinical trial: Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (NCT02314676)

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 B e 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.

          -  Potential tumor patients (family history).

          -  Diabetic.

          -  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.


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