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:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT03221933
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of small for gestational age, SGA.
* Chronological age between 2-6.5 years in girls and 2-7.5 years in boys. Both genders.
* Prepubertal stage (Tanner I).
* Without catch-up growth in two years after birth.
* Height was lower than the mean -2SD of the values of normal children of the same age and gender when participating in the study.
* A GH peak concentration \>10µg/L in a provocative test within a year before participate in the study.
* Bone age\<Chronological age+1.
* Normal glucose regulation：Fasting blood-glucose \< 5.6mmol/L and 2-hour postprandial blood glucose\< 7.8mmol/L.
* Gestational age≥Gestational age≥ 36weeks + 4days.
* Never accepted growth hormone treatment.
* The subjects and their guardians signed informed consent.
Exclusion Criteria:
* Subjects with Liver and renal insufficiency (ALT \> 2 times of upper limit of normal value, Cr\> upper limit of normal value).
* Patients with positive for antibodies to hepatitis B core (anti-HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)。
* Known highly allergic constitution or allergic to the test drug.
* Subjects with diabetes, severe cardiopulmonary and pulmonary disease, and hematological diseases, malignant tumors, or systemic infection, immunocompromised patients and patients with psychosis.
* Subjects with other types of abnormal growth and development, such as Turner syndrome, constitutional delay of puberty, Laron syndrome, growth hormone receptor deficiency.
* Subjects who have received the treatment of Somatropin or took part in other clinical trial study within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Months
Maximum Age:
90 Months
Study:
NCT03221933
Study Brief:
Protocol Section:
NCT03221933