Growth Hormone Deficiency
Conditions
Keywords
pegylated somatropin, PEG-rhGH, growth hormone, Growth Hormone Deficiency, phase III study
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). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.
Interventions
BIOLOGICALPEG-somatropin
drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months
Sponsors
Tongji Hospital
First Affiliated Hospital, Sun Yat-Sen University
Capital Medical University
Children's Hospital of Fudan University
The First Hospital of Jilin University
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 1\. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) * 2.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| yearly growth velocity | 6 months | growth velocity add as GV was the primary outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ht SDSca | 6 months | Ht SDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age |
| IGF-l | 6 months | — |
| IGFBP-3 | 6 months | — |
| bone maturity | 6 months | — |
Countries
China
Outcome results
None listed