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

Growth Hormone Deficiency Clinical Trial

— Phase 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613573
• Other study ID #: GenSci-004 Clinical Trial
• 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

• Dwarfism, Pituitary
• Growth Hormone Deficiency

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