Actively Recruiting
Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of primary immune thrombocytopenia (ITP)
- Age 14 years or older
- Prior treatment with at least one ITP therapy including a minimum 4-week course of oral TPO-RA (hetrombopag or eltrombopag) discontinued due to insufficient response
- Platelet count less than 30 x 10⁹/L at screening, or less than 50 x 10⁹/L with clinically significant bleeding
- Stable glucocorticoid dose (not exceeding 4 tablets daily) for at least 2 weeks
- Stable dosing of any other immunosuppressants for at least 4 weeks before enrollment
- No intravenous immunoglobulin within 2 weeks before first study dose
- No platelet transfusion within 1 week before first study dose
You will not qualify if you...
- Secondary ITP due to other autoimmune disorders, viral infections, or drug exposure
- Active malignancy
- Pregnancy
- Significant cardiovascular or cerebrovascular disease
- History of arterial or venous thrombosis
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
H
Hong Tian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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