Clinical trial: A Study of PEG-somatropin Injection to Treat Children of Turner Syndrome (NCT03189160)

Eligibility criteria:
Inclusion Criteria:

          -  Female

          -  Bone age <12 years

          -  Karyotype: 45, X; 45, X / 46, XXqi; 45, X / 46, XXr; 45, X / 46, XX; 46, XXqi; 46,
             XXpi; 45, X / 47, XXX; 46, XXp-; 45, X / 46, XXp-; 46, XXq-; 45X / 46, XXq-; 45, X /
             46, XX / 47, XXX, etc. (count 50 or more cells);

          -  Facial appearance and abnormalities: Patients with at least one of the following
             signs, which include but are not limited to facial pigmented nevus, short neck, webbed
             neck, low posterior hairline, low-set ears, micrognathia, high-voulted arch,
             shield-like chest, cubitus valgus, genu valgum, short 4th and 5th metacarpals, nail
             dysplasia, scoliosis, ptosis and strabismus, cardiovascular abnormalities (such as
             aortic stenosis, bicuspid aortic valve and hypertension), reproductive abnormalities
             (such as primary gonadal dysfunction), renal abnormalities, thyroid hypofunction,
             middle ear lesion, etc.

          -  Short stature: height below -2.5SD of the mean height of the same age and gender.

          -  Pre-pubertal (Tanner Stage I ) patients

          -  No history of growth hormone treatment

          -  The subject and his/her guardian sign the informed consent (if the subject is
             incapable to sign the informed consent, his/her legal guardian shall sign the name of
             the subject instead)

        Exclusion Criteria:

          -  Subjects with abnormal liver and kidney functions (ALT > upper limit of normal value;
             Cr > upper limit of normal value)

          -  Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests;

          -  Subjects with highly allergic constitution or allergy to proteins or investigational
             product or its excipient

          -  Subjects with systemic chronic disease and immune deficiency

          -  Patients diagnosed with tumor

          -  For patients whose tumor markers exceeding normal range in combination with other
             information, considering as potential high risks of tumor, they may be excluded from
             the treatment.

          -  Patients with mental disease

          -  Subjects with impaired glucose regulation (IGR) (including impaired fasting glucose
             (IFG) and/or impaired glucose tolerance (IGT) ) or diabetes

          -  Subjects who took part in other clinical trials within 3 months

          -  Subjects who received medicines which may interfere GH secretion or GH function, or
             other hormones within 3 months (such as sex steroids, glucocorticoids, etc.)

          -  Other conditions which are unsuitable for this study in the opinion of the
             investigator.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 2 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