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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT04737850
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 6 years old and ≤ 17 years old,both sexes.
2. Part A:Confirmed diagnosis of ITP ≥6months; Part B: Confirmed diagnosis of ITP ≥12months;Platelets \<30×10\^9/L twice in a row,and platelets \<30×10\^9/L before taking the medicine.
3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.
4. Birth control during and 28 days after the trial.
5. Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 8 years old).
Exclusion Criteria:
1. No evidence of other causes of thrombocytopenia.
2. Diagnosis as Evans or Wiskott-Aldrich comprehensive.
3. Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.
4. Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.
5. ALT, AST, or ALP\> 1.5 x upper limit of normal (ULN), DBLI, or Scr \> 1.2 x upper limit of normal (ULN).
6. Active HIV or HCV-Ab positive,HBsAg positive.
7. PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s
8. Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication.
9. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT04737850
Study Brief:
Protocol Section:
NCT04737850