Clinical Trial: Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlle
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 Summary:
Sponsor: GeneScience Pharmaceuticals Co., Ltd.
Current Primary Outcome: Growth velocity [ Time Frame: 25 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- height standard deviation score for chronological age (Ht SDSCA) [ Time Frame: 25 weeks ]
- IGF-1 [ Time Frame: 25 weeks ]
- IGFBP3 [ Time Frame: 25 weeks ]
Original Secondary Outcome: height standard deviation score for chronological age (Ht SDSCA)and IGF-1 and IGFBP3 [ Time Frame: 25 weeks ]
Information By: GeneScience Pharmaceuticals Co., Ltd.
Dates:
Date Received: April 21, 2011
Date Started: May 2006
Date Completion:
Last Updated: May 9, 2011
Last Verified: May 2011
