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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01613573
Other study ID # GenSci-004 Clinical Trial
Secondary ID
Status Completed
Phase Phase 1
First received June 1, 2012
Last updated June 13, 2012
Start date March 2010
Est. completion date November 2010

Study information

Verified date October 2010
Source GeneScience Pharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Male
Age group 4 Years to 10 Years
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
somatropin AQ
somatropin injection 0.2mg/kg/w once per day, inject for 7 continuous days 4 weeks for cleaning period
pegylated somatropin
Pegylated somatropin 0.2mg/kg/w once per week, for continuous 6 weeks Subcutaneous injection

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
GeneScience Pharmaceuticals Co., Ltd. Huazhong University of Science and Technology

Outcome

Type Measure Description Time frame Safety issue
Primary pharmacokinetics parameter 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) 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 No
Secondary IGF-1, IGFBP-3 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 Yes
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