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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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Somatropin
U.S. FDA Resources

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

Primary Outcome Measures:
  • yearly growth velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    growth velocity add as GV was the primary outcome measure


Secondary Outcome Measures:
  • 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 ]

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
  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495468

Locations
China
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
Investigators
Principal Investigator: Xiaoping Luo, Ph. D Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01495468     History of Changes
Other Study ID Numbers: GenSci-004-CT
Study First Received: December 16, 2011
Last Updated: December 16, 2011
Health Authority: China: Ethics Committee
China: Food and Drug Administration

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

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013