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

This study has been completed.
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. Identifier:
First received: December 16, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted

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.

Condition Intervention Phase
Growth Hormone Deficiency
Biological: PEG-somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial

Resource links provided by NLM:

Further study details as provided by GeneScience Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • yearly growth velocity [ Time Frame: 6 months ]
    growth velocity add as GV was the primary outcome measure

Secondary Outcome Measures:
  • Ht SDSca [ Time Frame: 6 months ]
    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 ]
  • IGFBP-3 [ Time Frame: 6 months ]
  • bone maturity [ Time Frame: 6 months ]

Enrollment: 343
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01495468

Beijing, China
Changchun, China
Guangzhou, China
Hangzhou, China
Shanghai, China
Wu Han, China
Sponsors and Collaborators
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 Tongji Hospital
  More Information

Responsible Party: GeneScience Pharmaceuticals Co., Ltd. Identifier: NCT01495468     History of Changes
Other Study ID Numbers: GenSci-004-CT
Study First Received: December 16, 2011
Last Updated: December 16, 2011

Keywords provided by GeneScience Pharmaceuticals Co., Ltd.:
pegylated somatropin
growth hormone
Growth Hormone Deficiency
phase III study

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 24, 2017