Status:
RECRUITING
Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Primacy Immune Thrombocytopenia
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The primary objective of this trial is to assess the efficacy and safety of combining Romiplostim N01 with Rituximab for the treatment of adult patients with primary immune thrombocytopenia (ITP) whos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07206823
Start Date
September 1 2025
End Date
July 31 2027
Last Update
December 4 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China