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Safety and Efficacy of Zanubrutinib in the Treatment of Immune Thrombocytopenia

Who is this study for? Patients with immune thrombocytopenia
What treatments are being studied? Zanubrutinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the safety and efficacy of zanubrutinib in the treatment of immune thrombocytopenia in 30 patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 and above, male or female;

• Conform to the diagnostic criteria of immune Thrombocytopenia (ITP);

• Diagnosis of ITP\>3 months;

• Primary ITP with a platelet count of \<30 X 109/L prior to inclusion with failure to achieve response or relapse after corticosteroid therapy, and at least one second-line therapy including rituximab \>12 weeks ago and/or TPO-RAs.

• Liver and kidney function, such as ALT, AST, BUN, SCR \< 1.5 × upper limit of normal value, passing physical examination;

• ECOG physical state score ≤ 2 points;

• Cardiac function of the New York Society of Cardiac Function ≤ 2;

• Signed and dated written informed consent.

Locations
Other Locations
China
Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yunfei Chen
chenyunfei@ihcams.ac.cn
+8618502220788
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Intervention ( zanubrutinib)
30 enrolled patients are picked up to take zanubrutinib at the indicated dose.
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov