Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

Qualifiers

Signed written informed consent

Age from 18 to 60 years old

Diagnosed with ITP and have a platelet count of <30 ×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 patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy.

Disqualifiers

Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.

Pregnant or lactating women;

Subjects is currently receiving treatment with another study medication.

Any laboratory or clinical evidence for HIV infection.

Trial design

Treatments tested in this trial

  • eltrombopag combining rituximab
  • eltrombopag

Treatment groups

224 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

The Second Affiliated Hospital of Kunming Medical University

Collaborator

Henan Cancer Hospital

Collaborator

Tianjin Medical University Second Hospital

Collaborator

The First Affiliated Hospital of Xiamen University

Collaborator

Affiliated Hospital of Nantong University

Collaborator