Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

Launched by CHANGCHUN GENESCIENCE PHARMACEUTICAL CO., LTD. · Sep 19, 2017

Keywords

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Gender

ALL

Eligibility criteria

• 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.