Actively Recruiting
Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-04-29
224
Participants Needed
1
Research Sites
521 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
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.
CONDITIONS
Official 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
- No response or relapse after splenectomy at least 6 months ago, or no splenectomy with no response or relapse after prior therapies
- Completed previous ITP treatments or not increasing dose after enrollment
- No cardiac disease in last 3 months, no arrhythmia increasing thrombotic risk, and QTc within specified limits
- No infection within the last 1 month
- Normal coagulation tests within 20% of normal, no clotting disorder other than ITP
- White blood cell counts, neutrophils, and hemoglobin within specified ranges
- Blood chemistry tests within 20% of normal, albumin not below normal by more than 10%
- Non-childbearing or using acceptable contraception
- Able and willing to comply with study requirements and complete study
You will not qualify if you...
- History of arterial or venous thrombosis or risk factors such as cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome
- Pregnant or lactating women
- Currently receiving treatment with another study medication
- Evidence of HIV infection
- History or evidence of active hepatitis B or C infection
- History of platelet aggregation affecting count measurement
- Any other clinical abnormalities making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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