NCT04518475

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

A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study was to evaluate the efficacy and safety of eltrombopag combining rituximab treating previously treated ITP patients compared to eltrombopag. The secondary objective was to evaluate the efficacy of eltrombopag combining rituximab in ITP patients with positive autoantibody compared to eltrombopag .In addition, health-related quality of life (HRQoL) measure was assessed in all participants. 224 eligible subjects were randomized to either eltrombopag combining rituximab or eltrombopag treatment in 1:1 ratio. 112 enrolled patients are randomly picked up to take eltrombopag combining with rituximab at the indicated dose. 112 enrolled patients are randomly picked up to take eltrombopag at the indicated dose. The initial dose of eltrombopag administration was an oral 75 mg once daily in all participants .The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. Subjects in eltrombopag combining rituximab treatment group received single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-10
• Primary completion: 2022-02-10
• Completion: 2022-08-10
• First posted: 2020-08-19
• Last updated: 2020-08-19

Locations

1 site across 1 country: China