National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed an… (NCT07268898) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
National Multicenter Retrospective Real-World Study on the Treatment Status of Newly Diagnosed and Persistent Primary Immune Thrombocytopenia (ITP) Patients
500 participantsStarted 2025-11-25
Plain-language summary
This study is a nationwide, multicenter, retrospective, real-world, non-interventional (observational) investigation. It retrospectively collects data on treatment modalities and therapeutic responses in patients with newly diagnosed or persistent immune thrombocytopenia (ITP), documents disease progression in both treated and untreated patients, and records the treatment regimens selected by those receiving therapy. The study aims to observe and evaluate the current treatment landscape for newly diagnosed and persistent ITP patients, while also analyzing the efficacy and safety in the treated population. All patient treatments and disease management are solely based on routine clinical practice and are not influenced by this study.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Availability of traceable inpatient medical records;
Clinically diagnosed with newly diagnosed or persistent ITP (ITP disease course ≤12 months) between July 2021 and September 2025;
Baseline platelet count \<30×10⁹/L;
Age ≥6 years;
Inclusion of patients regardless of ITP treatment status, encompassing those receiving any ITP-directed therapy (excluding emergency treatments such as platelet transfusion) and untreated patients (who have not received ITP-specific treatments including glucocorticoids, intravenous immunoglobulin, TPO-RAs, splenectomy, and rituximab).
Exclusion Criteria:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients achieving a platelet count ≥30×10⁹/L within 8 weeks, with at least a twofold increase from baseline, and no bleeding manifestations
Timeframe: 2026.2.25
Trial details
NCT IDNCT07268898
SponsorInstitute of Hematology & Blood Diseases Hospital, China