Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children (PD)

This study has been completed.
Sponsor:
Collaborators:
Huazhong University of Science and Technology
First Affiliated Hospital, Sun Yat-Sen University
Capital Medical University
Children's Hospital of Fudan University
Information provided by:
GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01342146
First received: April 21, 2011
Last updated: May 9, 2011
Last verified: May 2011

April 21, 2011
May 9, 2011
May 2006
January 2007   (final data collection date for primary outcome measure)
Growth velocity [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
Growth velocity [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01342146 on ClinicalTrials.gov Archive Site
  • height standard deviation score for chronological age (Ht SDSCA) [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • IGF-1 [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
  • IGFBP3 [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
height standard deviation score for chronological age (Ht SDSCA)and IGF-1 and IGFBP3 [ Time Frame: 25 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Hormone Deficiency
  • Drug: pegylated Somatropin
    0.1 mg/kg/wk once a week for 25 weeks
    Other Name: PEG-rhGH,PEG-growth hormone,PEG-Somatropin
  • Drug: pegylated Somatropin
    0.2 mg/kg/wk once a week for 25 weeks
    Other Name: PEG-rhGH,PEG-growth hormone,PEG-Somatropin
  • Drug: Jintropin AQ
    0.25 mg/kg/wk, once a day for 25 weeks
    Other Name: Somatropin injectable solution,rhGH injection
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
February 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01342146
GenSci-004 CT
Yes
International Regulatory Affairs Department, GeneScience Pharmaceuticals Co., Ltd.
GeneScience Pharmaceuticals Co., Ltd.
  • Huazhong University of Science and Technology
  • First Affiliated Hospital, Sun Yat-Sen University
  • Capital Medical University
  • Children's Hospital of Fudan University
Principal Investigator: Xiaoping Luo, Doctor Huazhong University of Science and Technology
GeneScience Pharmaceuticals Co., Ltd.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP