Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children
Information source: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: somatropin AQ (Drug); pegylated somatropin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GeneScience Pharmaceuticals Co., Ltd. Official(s) and/or principal investigator(s):
Luo Xiaoping, Doctor, Principal Investigator, Affiliation: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
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.
Clinical Details
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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: pharmacokinetics parameter
Secondary outcome: IGF-1, IGFBP-3
Eligibility
Minimum age: 4 Years.
Maximum age: 10 Years.
Gender(s): Male.
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
Locations and Contacts
Additional Information
Starting date: March 2010
Last updated: June 13, 2012
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