Status:
COMPLETED
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Tongji Hospital
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
8-15 years
Phase:
PHASE3
Brief Summary
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). A...
Eligibility Criteria
Inclusion
- 1\. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration \<7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year 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.
- sign informed consent
Exclusion
- 1\. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
- Known hypersensitivity to Somatropin or any other components of the study product.
- 3\. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
- 4\. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
- 5\. Subjects took part in other clinical trial study during 3 months.
- 6\. Other conditions which in the opinion of the investigator preclude enrollment into the study.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT01495468
Start Date
March 1 2007
End Date
March 1 2008
Last Update
July 31 2017
Active Locations (6)
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1
Beijing, China
2
Changchun, China
3
Guangzhou, China
4
Hangzhou, China