Status:
UNKNOWN
Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Growth Retardation
Eligibility:
All Genders
42-15 years
Phase:
PHASE4
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 effi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03290235
Start Date
March 1 2017
End Date
September 1 2021
Last Update
December 12 2017
Active Locations (1)
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1
TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology
Wuhan, Hubei, China