Actively Recruiting
A Multicenter, Randomized, Open-label Study Comparing Eltrombopag with Rituximab Versus Eltrombopag Alone in Adult Primary Immune Thrombocytopenia (ITP) Patients
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-04-29
224
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
The Second Affiliated Hospital of Kunming Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining eltrombopag with rituximab compared to eltrombopag alone in adult patients in China who have primary immune thrombocytopenia (ITP) and have not responded to or relapsed after previous treatments, including first-line therapies and/or splenectomy. This randomized, open-label study aims to understand if the combined treatment improves patient outcomes and quality of life. The study is sponsored by the Institute of Hematology & Blood Diseases Hospital in China. Participants are randomly assigned to one of two groups: one receiving eltrombopag with a single rituximab infusion and the other receiving eltrombopag alone. All participants start with an oral eltrombopag dose of 75 mg daily, adjusted weekly based on platelet counts over 24 weeks. Those in the combination group receive a single rituximab infusion within 14 days of enrollment. Treatment response and safety are assessed at weeks 4, 8, and 12. Throughout the study, participants undergo weekly blood tests to monitor platelet levels and safety. Researchers measure treatment response up to week 12, as well as longer-term responses and quality of life through questionnaires up to week 24. The study also tracks bleeding events and side effects. Participants are observed from treatment start through 24 weeks to evaluate how well the treatments work and their impact on daily living.
CONDITIONS
Brief Title
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Age from 18 to 60 years old
- Diagnosed with ITP and have a platelet count of <30 x 10^9/L on Day 1 (or within 48 hours prior to dosing on Day 1)
- Patients who have no response or relapsed after splenectomy (at least more than 6 months) or have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy
- Subjects treated with previous therapy (including corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have completed treatment prior to randomization or not be increasing dose after enrollment
- No pre-existing cardiac disease within the last 3 months and no arrhythmia increasing thrombotic risk (e.g., atrial fibrillation) or abnormal QT interval
- No pre-existing infection within the last 1 month
- Normal coagulation function tests within 20% of normal range and no clotting disorder other than ITP
- White blood cell count, neutrophil absolute value, hemoglobin within reference ranges with exceptions: hemoglobin ≥10.0 g/dl, ANC ≥1500/μL
- Blood chemistry tests (ALT, AST, bilirubin, creatinine, albumin) within 20% above normal or 10% below lower limit
- Non-childbearing or using acceptable contraception throughout the study
- Able to comply with study requirements and willing to complete the study as planned
You will not qualify if you...
- History of arterial or venous thrombosis and risk factors like cancer, Factor V Leiden, ATIII deficiency, or antiphospholipid syndrome
- Pregnant or lactating women
- Currently receiving treatment with another study medication
- Evidence of HIV infection
- History or active hepatitis C or chronic hepatitis B infection
- History of platelet aggregation preventing reliable platelet count measurement
- Any clinically relevant abnormality other than ITP making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive eltrombopag treatment orally once daily, with the dose adjusted weekly based on platelet counts from week 1 to week 24. Participants in one group also receive a single infusion of rituximab within 14 days after enrollment. Efficacy and safety are evaluated at weeks 4, 8, and 12.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
Actively Recruiting
Research Team
L
Lei Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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