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
Study ID
NCT07206823
Status
Recruiting
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Conditions

  • Primacy Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Romiplostim N01 — DRUG
    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 — DRUG
    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.

Study Details

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).

Key Dates

Start date
Sep 1, 2025
Status verified
Sep 2025
Primary completion
Feb 28, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Romiplostim N01 + Rituximab Combination Therapy

Primary Outcome Measure

Efficacy evaluation [ Time Frame: from week 2 to month 12 ]

Central Contacts