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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT07194850
Eligibility Criteria:
Inclusion Criteria:
* Is aged 12 to less than 18 years when completing the informed consent process
* Has a documented duration of primary ITP of more than 12 months on the date the informed consent process is complete
* Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, IVIg, anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.
* Has documented prior response, defined as 1 platelet count of ≥50 × 10\^9/L to at least 1 of the following ITP treatments: prednisone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin
* Has documented insufficient response to a prior ITP treatment with corticosteroids, IVIg, anti-D immunoglobulin, TPO-RAs, rituximab, or splenectomy
* Has documented mean platelet count of less than 30 x10\^9/L
Exclusion Criteria:
* Secondary ITP according to the following definition by the International Working Group (IWG): all forms of immune-mediated thrombocytopenia except primary ITP
* Nonimmune thrombocytopenia
* ITP-associated critical or severe bleeding
* History of hereditary thrombocytopenia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT07194850
Study Brief:
Protocol Section:
NCT07194850