Last updated on February 2015

Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Small for Gestational Age Infant
  • Age: Between 3 - 7 Years
  • Gender: Male or Female
  • Other:
    The patients are diagnosed as being clinically full term small for gestational age
    infant.
    Girl are 3-6 years old, boys are 3-7 years old.
    Be in preadolescence (Tanner stage 1).
    The child did not achieve catch-up growth when he/she entered the group (the
    definition of catch-up growth is that the height is higher the third percentile with
    the same age and gender) (Appendix 2 and 3).
    The height of child is shorter than -2SDS of the median of normal children with the
    ame age and gender when he/she entered the group (the mean height and height
    tandard deviation of normal children with the same age and gender of normal children
    regard the height data in the physical development investigation data of children
    aged 0-18 in 9 cities of China (2005) as standard [13], Appendix 4 and 5).
    Within a year before entering the group, after any growth hormone stimulation test,
    the peak concentration of growth hormone in serum>10 µg/L.
    Bone age≤ the actual age+1.
    The function of glucose regulation is normal: fasting blood glucose < 5.6mmol/L.
    Birth gestational age ≥ 37 weeks.
    The subjects and their guardians sign the informed consent (if the subjects is lack
    of ability for signing the informed consent, his legal guardian can write the
    ubjects name instead).

You may not be eligible for this study if the following are true:

  • People with abnormal liver or kidney function (ALT> 2 times the upper limit of normal
    value, Cr> the upper limit of normal value).
    Patients are 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 or the
    excipient of the study.
    People with diabetes, severe cardiopulmonary, hematological system and malignant
    tumors diseases or general infection, immune deficiency and patients with mental
    disease.
    Other abnormal growth and development, such as Turner syndrome, Laron syndrome,
    growth hormone receptor deficiency.
    Potential tumor patients (family history).
    Patients who used growth hormone for treatment.
    Subjects took part in other clinical trial study within 3 months.
    Patients used other hormonal for treatment within 3 months (such as sex hormone,
    glucocorticoid and etc., treat for more than a month) and received the drug treatment
    which may interfere with the secretion of GH or GH function (oxandrolone, growth
    hormone releasing hormone and etc.);
    Other conditions which in the opinion of the investigator preclude enrollment into
    the study.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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