Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children (PD)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
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