Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

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
First Hospital of Jilin University
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01495468
First received: December 16, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

December 16, 2011
December 16, 2011
March 2007
January 2008   (final data collection date for primary outcome measure)
yearly growth velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
growth velocity add as GV was the primary outcome measure
Same as current
No Changes Posted
  • Ht SDSca [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age
  • IGF-l [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • IGFBP-3 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • bone maturity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).

All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.

Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Hormone Deficiency
Biological: PEG-somatropin
drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months
Other Names:
  • recombinant human growth hormone
  • peglyated growth hormone
  • PEG-GH
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
343
March 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year 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:

  • 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
  • 2.Known hypersensitivity to Somatropin or any other components of the study product.
  • 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
  • 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
  • 5. Subjects took part in other clinical trial study during 3 months.
  • 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.
Both
8 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01495468
GenSci-004-CT
Yes
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
  • First Hospital of Jilin University
Principal Investigator: Xiaoping Luo, Ph. D Huazhong University of Science and Technology
GeneScience Pharmaceuticals Co., Ltd.
December 2011

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