Growth Retardation
Conditions
Brief summary
1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period 2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.
Interventions
DRUGPEG-somatropin
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Months to 15 Years
Healthy volunteers
No
Inclusion criteria
* Children has completed all visits and therapy in previous phase IV study; * Investigators evaluate subjects could continue growth hormone therapy; * Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.
Exclusion criteria
* Children with epiphyseal closure; * Children is near the adule final height, that is, growth rate≤ 2 cm / year or bone age ≥ 14 years old for girls, bone age ≥ 16 years old for boys; * Dysfunction of liver and kidney (ALT\> 2 times the upper limit of normal, Cr\> upper limit of normal); * Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any other components of the study product; * Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; * Patients with diabetics; * Patients with congenital bone dysplasia or scoliosis; * Patients took drugs that would influence the efficacy and safety of PEG-Somatropin after phase IV study and before screening for this extension study; * Other conditions in which the investigator preclude enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ht SDSca (Height standard deviation score for chronological age) | Baseline, every 13 weeks until 130 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ht SDSBA (Height standard deviation score for bone age) | Baseline, every 13 weeks until 130 weeks | — |
| Yearly growth velocity | Baseline, every 13 weeks until 130 weeks | — |
| IGF-1 SDS (Standard deviation score of insulin-like growth factor-1) | Baseline, every 13 weeks until 130 weeks | — |
| Bone age | Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks | — |
| Near final height for some subjects | Baseline, every 13 weeks until 130 weeks | When yearly growth velocity of some subject is no more than 2cm/year. |
Countries
China
Contacts
Primary ContactXiaohua Feng
Outcome results
None listed