Clinical Trial: Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II

Brief Summary: To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

Detailed Summary:
Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Current Primary Outcome: The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA) [ Time Frame: 26 weeks ]

HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • HtSDSBA [ Time Frame: 26 weeks ]
    HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender
  • Annual height velocity [ Time Frame: 26 weeks ]
    Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)
  • Standard Deviation Score of serum IGF-1 (IGF-1 SDS) [ Time Frame: 26 weeks ]
    IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age
  • Bone Maturation [ Time Frame: 26 weeks ]
    Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)


Original Secondary Outcome: Same as current

Information By: GeneScience Pharmaceuticals Co., Ltd.

Dates:
Date Received: September 19, 2016
Date Started: November 2014
Date Completion:
Last Updated: September 20, 2016
Last Verified: September 2016