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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT06686927
Eligibility Criteria:
Inclusion Criteria:
1. Participants must sign a written informed consent prior to enrollment;
2. Ages 18-75;
3. Platelet count \<10×10\^9/L with active bleeding or bleeding score ≥5;
4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
6. No prior romiplostim treatment;
7. ECOG PS score: 0-2;
8. Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;
9. Voluntary participation in this study and good compliance.
Exclusion Criteria:
1. Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
2. Individuals with a history of thrombosis;
3. Pregnant or lactating individuals;
4. Individuals with severe cardiopulmonary insufficiency;
5. Individuals with severe or uncontrollable infections;
6. Individuals with viral infections;
7. Individuals who cannot comply due to psychological reasons;
8. Individuals who are deemed unsuitable for participation in the study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06686927
Study Brief:
Protocol Section:
NCT06686927