Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children (PD)
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The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
have a height less than two standard deviations (SD) below the median height for individuals of the same age or height, a growth velocity (GV) ≤4 cm/yr, a GH peak concentration <7 ng/ml in two different provocative tests, a bone age (BA; ≤9 years in girls and ≤10 years in boys) at least 2 years less than his/her chronological age (CA);
be in preadolescence (Tanner stage 1) and have a CA >3 years;
have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV;
receive no prior GH treatment.
sign informed consent
patients with severe cardiopulmonary
patients with hematological diseases
a current or past history of malignant tumors
patients positive for hepatitis B e-antibody (HBeAb)
hepatitis B surface antigen (HBsAg)
hepatitis B e antigen (HBeAg)
patients with other growth disorders, such as Turner syndrome
constitutional delay of growth and puberty, and Laron syndrome
Keywords provided by GeneScience Pharmaceuticals Co., Ltd.:
PEG-GH Growth hormone
PEG-rhGH Growth hormone deficiency (GHD)
Phase 2 study
Additional relevant MeSH terms:
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Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs