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

Summary

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

• Primary Immune Thrombocytopenia (ITP)

Interventions

DRUG

eltrombopag combining rituximab

After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.

DRUG

eltrombopag

After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Tianjin Medical University Second Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Affiliated Hospital of Nantong University

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Principal Investigators

• Lei Zhang, M.D., Ph.D · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-10

Primary Completion

2029-02-10

Completion

2030-08-10

Countries

• China

Study Locations