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

This study has been completed.
Sponsor:
Collaborator:
Huazhong University of Science and Technology
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01613573
First received: June 1, 2012
Last updated: June 13, 2012
Last verified: October 2010
  Purpose

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 Intervention Phase
Growth Hormone Deficiency
Drug: somatropin AQ
Drug: pegylated somatropin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Male
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613573

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

No publications provided

Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01613573     History of Changes
Other Study ID Numbers: GenSci-004 Clinical Trial
Study First Received: June 1, 2012
Last Updated: June 13, 2012
Health Authority: China: Ethics Committee
China: Food and Drug Administration

Keywords provided by GeneScience Pharmaceuticals Co., Ltd.:
pegylated Somatropin
PEG-GH
Phase 1 study
Pharmacokinetics

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

ClinicalTrials.gov processed this record on April 17, 2014