Romiplostim N01 plus rituximab for people with primary immune thrombocytopenia unresponsive to oral TPO‑RAs
Official title: An Open-label, Single-arm, Single-center Study to Evaluate the Efficacy and Safety of Romiplostim N01 in Combination With Rituximab in Patients With Primary Immune Thrombocytopenia Refractory to Oral TPO-RAs
Run by The First Affiliated Hospital of Soochow University · NCT07206823 · Data updated 2026-11-12
This study will test whether weekly romiplostim N01 injections combined with a four‑week course of rituximab can raise platelet counts in people aged 14 and older whose ITP did not respond to oral TPO‑RAs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | prednisone, Rituximab |
| Locations | 1 site (Suzhou, Jiangsu) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | February 28, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07206823 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 14 or older with confirmed primary ITP who failed to respond to at least a four‑week course of an oral TPO‑RA and meet the study's platelet and medication‑stability criteria.
✕Probably not a fit
Patients with secondary ITP, recent IVIG or platelet transfusion, or those whose ITP responded to oral TPO‑RAs are unlikely to meet eligibility or gain benefit from this specific combination in 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 is an open‑label, single‑arm trial enrolling about 30 participants aged 14 years or older with primary ITP refractory to oral TPO‑RAs. All participants receive rituximab by intravenous infusion once weekly for four weeks and weekly romiplostim N01 injections with dose adjustments based on platelet counts. Participants will have regular clinic visits for blood tests, bleeding symptom reporting, and safety monitoring. The main goals are to determine whether this combination increases platelet counts and to monitor adverse effects.
Why it matters
Potential benefit: If successful, the combination could raise platelet counts and reduce bleeding for people who did not respond to oral TPO‑RAs, offering a new treatment option.
How similar studies have gone: Rituximab and romiplostim have each shown benefit in ITP, and combination approaches have been explored in small studies, but combined therapy is not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Confirmed diagnosis of primary immune thrombocytopenia (ITP). Age ≥14 years. Prior exposure to at least one ITP-directed therapy (e.g., corticosteroids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO-RAs, immunosuppressants, or splenectomy), including a minimum 4-week course of an oral TPO-RA (hetrombopag or eltrombopag) that was discontinued due to insufficient response. Platelet count \< 30 × 10⁹/L at screening, OR platelet count \< 50 × 10⁹/L with concurrent clinically significant bleeding. Stable glucocorticoid dose (e.g., prednisone or methylprednisolone, not exceeding 4 tablets daily) for at least 2 weeks, and stable dosing of any other immunosuppressants for at least 4 weeks prior to enrollment. No receipt of intravenous immunoglobulin within 2 weeks before the first dose of study treatment. No platelet transfusion within 1 week before the first dose of study treatment. Exclusion Criteria: Secondary ITP due to underlying conditions such as other autoimmune disorders, viral infections, or drug exposure. Presence of active malignancy, pregnancy, significant cardiovascular or cerebrovascular disease, or history of arterial/venous thrombosis.
Where it's running
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Hong Tian
- Email: tianhong0718@163.com
- Phone: +86 0512 67781521
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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.