Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
NCT04518475

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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