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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT05070234
Eligibility Criteria:
Inclusion Criteria:
1. Single birth, clinical diagnosis of SGA;
2. rhGH treatment beginned before puberty (Tanner stage I), regardless of gender;
3. Before starting rhGH treatment, height was lower than -2 SDS compared with normal children of the same age and sex;
4. All the subjects and their guardians signed the informed consent and the informed consent for genetic testing.
Exclusion Criteria:
1. No efficacy and safety data were recorded after treatment with rhGH;
2. A history of blood transfusion within 3 months before the collection of the genetic blood samples, or a history of bone marrow transplantation between rhGH treatment and the enrollment in this study;
3. Other conditions that the investigator considered unsuitable for inclusion in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
20 Years
Study:
NCT05070234
Study Brief:
Protocol Section:
NCT05070234