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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT04518475
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • eltrombopag combining rituximab — DRUG
    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.
  • eltrombopag — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 10, 2020
Status verified
Apr 2026
Primary completion
Feb 10, 2029
Completion
Aug 10, 2030

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efficacy of 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.
  • Active Comparator: efficacy of 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.

Primary Outcome Measure

Treatment response [ Time Frame: From the start of study treatment (Day 1) up to the end of week 12. ]

Central Contacts

Related Studies