Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
Phase 2
Completed
- Conditions
- Growth Hormone Deficiency
- Registration Number
- NCT01342146
- Lead Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Growth velocity 25 weeks
- Secondary Outcome Measures
Name Time Method height standard deviation score for chronological age (Ht SDSCA) 25 weeks IGFBP3 25 weeks IGF-1 25 weeks