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Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
Sponsor: The First Affiliated Hospital of Soochow University
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) whose disease is refractory to oral TPO-RAs. All participants in this study will receive the same combination treatment: Rituximab: Given once a week through an intravenous infusion for 4 weeks. Romiplostim N01: Given as a weekly injection，the dose may be adjusted each week based on the patient's platelet count. Participants will be asked to: Visit the clinic regularly for check-ups, blood tests (to monitor platelet counts), and safety assessments. Report their bleeding symptoms for evaluation. This is an open-label, single-arm trial, meaning that all participants will receive the investigational treatment, and both the research team and participants will be aware of the treatment assigned. The study aims to enroll approximately 30 adult patients aged 14 years or older who have been diagnosed with ITP and have not responded adequately to prior oral TPO-RAs (eltrombopag/hetrombopag).
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
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-09-01
Completion Date
2027-07-31
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
Romiplostim N01
Romiplostim N01 will be administered via subcutaneous injection once weekly based on the platele count. The starting dose is set at 3 μg/kg. Weekly dose adjustments will be guided by platelet counts measured immediately prior to administration, as follows: For a platelet count below 50 × 10⁹/L, the dose will be increased by 1 μg/kg. For a platelet count between 50 and 200 × 10⁹/L, the current dose will be maintained as the minimum therapeutic dose for bleeding risk reduction. For a platelet count between 200 and 400 × 10⁹/L, the dose will be decreased by 1 μg/kg. For a platelet count exceeding 400 × 10⁹/L, the administration will be withheld. It is stipulated that dosing will resume at a reduction of 1 μg/kg from the previous dose once the platelet count returns to 200 × 10⁹/L or below. Under no circumstances shall the dose exceed the maximum allowable limit of 10 μg/kg per week.
Rituximab
Rituximab will be administered in accordance with the Chinese guidelines for the diagnosis and management of adult primary immune thrombocytopenia (2020 edition). The dosage will be 375 mg/m² per infusion, administered via intravenous infusion once weekly for a total of four weeks.
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China