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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT01495468
Eligibility Criteria:
Inclusion Criteria:
* 1\. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration \<7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year less than his/her chronological age (CA)
* be in preadolescence (Tanner stage 1) and have a CA \> 3 years
* have a height value recorded 3 months before the start of GH treatment to calculate pre-treatment GV.
* receive no prior GH treatment.
* sign informed consent
Exclusion Criteria:
* 1\. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
* 2.Known hypersensitivity to Somatropin or any other components of the study product.
* 3\. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
* 4\. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
* 5\. Subjects took part in other clinical trial study during 3 months.
* 6\. Other conditions which in the opinion of the investigator preclude enrollment into the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
15 Years
Study:
NCT01495468
Study Brief:
Protocol Section:
NCT01495468