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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
 Drug: pegylated Somatropin
Drug: Jintropin AQ
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

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:
  • Growth velocity [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 101
Study Start Date: May 2006
Study Completion Date: February 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342146

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
Investigators
Principal Investigator: Xiaoping Luo, Doctor Huazhong University of Science and Technology
  More Information

No publications provided

Responsible Party: International Regulatory Affairs Department, GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01342146     History of Changes
Other Study ID Numbers: GenSci-004 CT
Study First Received: April 21, 2011
Last Updated: May 9, 2011
Health Authority: China: Ethics Committee
China: Food and Drug Administration

Keywords provided by GeneScience Pharmaceuticals Co., Ltd.:
pegylated Somatropin
PEG-GH
Growth hormone
 PEG-rhGH
Growth hormone deficiency (GHD)
Phase 2 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 16, 2013