Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT03290235
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
42 Months
Maximum Age:
15 Years
Study:
NCT03290235
Study Brief:
Protocol Section:
NCT03290235