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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT05685420
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who have completed PartB of HR-TPO-ITP-III-PED clinical trial and have achieved platelet response.
2. Subjects who have signed the informed consent for the extended study.
3. Subjects with potential fertility（e.g. women who have menarche or men who have sperm loss) should agree to use effective contraception during their participation in the extended study and within 28 days after their last dose.
4. Subjects who have completed end-of-treatment visits in the original study.
Exclusion Criteria:
1. Any unstable condition or condition that may compromise the safety of the subject.
2. Patients with new myelofibrosis were examined in the original clinical trial exit group.
3. The original clinical trial cohort examined evidence of new cataract or existing cataract progression, and the study considered it unsuitable to enroll in this extension.
4. Patients with uncontrolled bleeding after standard treatment.
5. Any previous occurrence of arterial or venous thrombosis (transient ischemic attack,myocardial infarction ,deep venous thrombus, or pulmonary embolism ),or clinical symptoms and history suggest thrombus susceptibility.
6. Any other circumstances that the investigator considers likely to cause the subject to be unable to complete the study or to present a significant risk to the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT05685420
Study Brief:
Protocol Section:
NCT05685420