Trial | NCT01342146  Report issue

Title

Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    somatropin jintropin ...

  • Study Participants

    101
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.
Study Started
May 31
2006
Primary Completion
Jan 31
2007
Study Completion
Feb 28
2007
Last Update
Jul 31
2017

Drug pegylated Somatropin

0.1 mg/kg/wk once a week for 25 weeks

  • Other names: PEG-rhGH,PEG-growth hormone,PEG-Somatropin

Drug pegylated Somatropin

0.2 mg/kg/wk once a week for 25 weeks

  • Other names: PEG-rhGH,PEG-growth hormone,PEG-Somatropin

Drug Jintropin AQ

0.25 mg/kg/wk, once a day for 25 weeks

  • Other names: Somatropin injectable solution,rhGH injection

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

patients with severe cardiopulmonary
patients with hematological diseases
a current or past history of malignant tumors
immunodeficiency diseases
mental diseases
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
No Results Posted