Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children (Phase 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613573
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : June 14, 2012
Huazhong University of Science and Technology
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief Summary:
The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: somatropin AQ Drug: pegylated somatropin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children
Study Start Date : March 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Intervention Details:
    Drug: somatropin AQ
    somatropin injection 0.2mg/kg/w once per day, inject for 7 continuous days 4 weeks for cleaning period
    Other Names:
    • Somatropin injection
    • rhGH
    Drug: pegylated somatropin
    Pegylated somatropin 0.2mg/kg/w once per week, for continuous 6 weeks Subcutaneous injection
    Other Names:
    • PEG somatropin
    • PEG GH
    • pharmacokinetics
    • growth hormone deficiency

Primary Outcome Measures :
  1. pharmacokinetics parameter [ Time Frame: Somatropin AQ: predose(0),1,2,3,4,6,8,10,12,16,20,24 hours post-dose. PEG somatropin: predose (0),2,4,8,12,18,24,36,48,72,96,120,144,168 hours post-dose ]
    Cmax, AUC during the time interval for the first dose and last dose, Half-Life(t1/2), Apparent body clearance(CL), Mean residence time(MRT),steady-state volume of distribution(Vss)

Secondary Outcome Measures :
  1. IGF-1, IGFBP-3 [ Time Frame: Day I to Day 7 in each treatment period (33 time points) for daily used somatropin, Day I to Day 42 in each treatment period (35 time points) for PEG somatropin ]

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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 or stop the GH treatment for more than 4 weeks;sign informed consent

Exclusion Criteria:

  • Patients with Liver and kidney dysfunction (ALT> upper limit of normal 2 times, Cr> upper limit of normal), hepatitis B virus detection, antigen-HBc, HBsAg and HBeAg are positive
  • patients with known to a highly allergic constitution or allergic to the drug of this study
  • Patients with diabetes, serious cardiopulmonary, blood system, malignant tumor and other diseases or systemic infection in immunocompromised and mental diseases
  • Patients with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, Laron syndrome, GH receptor deficiency, girls with growth delay have not ruled out chromosomal abnormalities
  • Participated in clinical trials of other drugs in 3 months
  • Other cases that the researchers considered unsuitable for this clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613573

Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Huazhong University of Science and Technology
Principal Investigator: Luo Xiaoping, Doctor Tongji Hospital

Responsible Party: GeneScience Pharmaceuticals Co., Ltd. Identifier: NCT01613573     History of Changes
Other Study ID Numbers: GenSci-004 Clinical Trial
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: October 2010

Keywords provided by GeneScience Pharmaceuticals Co., Ltd.:
pegylated Somatropin
Phase 1 study

Additional relevant MeSH terms:
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
Endocrine System Diseases