Long-term observation of children with primary immune thrombocytopenia
Official title: Clinical Characteristics, Prognosis and Prognostic Model of Pediatric Immune Thrombocytopenia: a Prospective, Multicenter, Observational Cohort Study
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT06107582 · Data updated 2026-11-12
This study looks at how children with primary immune thrombocytopenia are treated and what their long-term health outcomes are in order to better understand the condition.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Tianjin) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2036 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT06107582 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients aged 6-17 years diagnosed with primary immune thrombocytopenia.
✕Probably not a fit
Patients with secondary thrombocytopenia or those expected to have a follow-up period of less than 3 months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to analyze the clinical characteristics, treatment methods, and prognosis of pediatric patients diagnosed with primary immune thrombocytopenia (ITP) in China. It will collect data from medical records and utilize questionnaires to assess patient exposure, with a focus on long-term follow-up to gather prognostic information. The study seeks to establish a comprehensive understanding of ITP in children, addressing the current gaps in large-scale prospective cohort studies.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and quality of life for children suffering from primary immune thrombocytopenia.
How similar studies have gone: While there have been smaller cohort studies on pediatric ITP, this study aims to provide a novel and comprehensive approach by establishing a large-scale longitudinal cohort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6-17 years old (including both ends), male and female; * Diagnosis of ITP. Exclusion Criteria: * Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.; * The expected follow-up period is less than 3 months.
Where it's running
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Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, China Recruiting
Study contacts
- Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
- Study coordinator: Ting Sun, MD
- Email: sunting@ihcams.ac.cn
- Phone: 02223909009
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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What patients with primary ITP prefer in their treatment
This survey-based study in the US will ask adults with primary ITP about which treatment options they prefer and why.
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SG301 SC Injection safety in adults with primary ITP
This Phase 2 study tests SG301 SC injection at two doses versus placebo in adults with primary immune thrombocytopenia to see if it is safe and helps raise platelet counts.
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Romiplostim plus prednisone vs prednisone alone in adults with newly diagnosed ITP
This phase 3 trial tests whether adding romiplostim to prednisone helps adults with newly diagnosed primary ITP respond better than prednisone alone.
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TQB3473 tablets for treating adult primary immune thrombocytopenia
This study is testing if TQB3473 tablets can help adults with chronic immune thrombocytopenia who haven't responded well to standard treatments feel better and have more stable blood platelet levels.
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Using Eltrombopag as a first treatment for Primary Immune Thrombocytopenia
This study is testing if a new medication called eltrombopag can help people who are newly diagnosed with Primary Immune Thrombocytopenia by increasing their platelet counts and reducing bleeding.
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High-dose dexamethasone plus orelabrutinib versus placebo for newly diagnosed adult ITP
This trial tests whether adding orelabrutinib to high-dose dexamethasone helps adults newly diagnosed with primary ITP raise and maintain their platelet counts compared with placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.