Phase
Condition
Williams Syndrome
Growth Hormone Deficiencies/abnormalities
Treatment
N/AClinical Study ID
Ages 42-15 All Genders
Study Summary
Eligibility Criteria
Inclusion
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, treatmentplans and laboratory tests and other procedures, to sign informed consent.
Exclusion
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> upperlimit of normal);
Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any othercomponents of the study product;
Patients with severe cardiopulmonary or hematological diseases, a current or pasthistory 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-Somatropinafter phase IV study and before screening for this extension study;
Other conditions in which the investigator preclude enrollment into the study.
Study Design
Connect with a study center
TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology
Wuhan, Hubei
ChinaActive - Recruiting
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