|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01613573 |
|
Date of registration:
|
01/06/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children
Phase 1 |
|
Scientific 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 |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01613573 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 1
|
|
|
Contacts
|
|
Name:
|
Luo Xiaoping, Doctor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology |
| | |
|
Key inclusion & exclusion 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
Age minimum:
4 Years
Age maximum:
10 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Growth Hormone Deficiency
|
|
Intervention(s)
|
|
Drug: pegylated somatropin
|
|
Drug: somatropin AQ
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Secondary ID(s)
|
|
GenSci-004 Clinical Trial
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|