Clinical trial: Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency (NCT03249480)

Eligibility criteria:
Inclusion Criteria:

          -  Diagnosed as GHD before starting treatment, according to medical history, clinical
             symptoms and signs, GH provocation tests and imaging and other examinations:

               1. According to statistical height data of physical development of Chinese children
                  in nine cities in 2005, the height is lower than 3rd percentile growth curve of
                  the same age, same sex normal children;

               2. Height velocity (HV) ≤5.0 cm / yr;

               3. GH provocative tests (with two drugs of different mechanism of action) confirmed
                  plasma GH peak <10.0 ng / ml;

               4. bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more
                  later than the actual age, that is the actual age - bone age ≥ 1 year;

          -  Before puberty (Tanner I stage), age≥3 years old, male or female;

          -  Have not received hormone therapy within 6 months;

          -  Subjects is willing and able to cooperate to complete scheduled visits, treatment
             plans and laboratory tests and other procedures, to sign informed consent.

        Exclusion Criteria:

          -  Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper
             limit of normal);

          -  Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen
             (HBsAg) or hepatitis B e antigen (HBeAg);

          -  Patients with known hypersensitivity to PEG Somatropin or Somatropin or any other
             components of the study product;

          -  Patients with severe cardiopulmonary or hematological diseases, a current or past
             history of malignant tumors, immunodeficiency diseases, or mental diseases;

          -  Potential cancer patients (family history);

          -  Patients with diabetics;

          -  Patients with other growth disorders, such as Turner's syndrome, sexual physical
             delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly
             growing who did not rule out chromosomal abnormalities;

          -  Patients with congenital bone dysplasia or scoliosis;

          -  Subjects took part in other clinical trial study during 3 months;

          -  Other conditions in which 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? 0