A Study of Zanubrutinib in Patients With ITP

Peking University People's Hospital20 enrolled

Overview

This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).

The investigators are undertaking a prospective trial of 10 adults with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Immune Thrombocytopenia Bruton Tyrosine Kinase

Interventions

ZanubrutinibDRUG

Zanubrutinib 80mg po qd 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed primary refractory ITP * Platelet counts \<30×10\^9/L or with bleeding symptoms * Willing and able to sign written informed consent Exclusion Criteria: * Secondary thrombocytopenia * Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit * HIV infection or hepatitis B virus or hepatitis C virus infections * Malignancy * Severe medical condition (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) * Nursing or pregnant patients * Patients who are deemed unsuitable for the study by the investigator

Locations (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Overall response (OR)

The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-week follow-up.

Time frame: 6 weeks

Secondary Outcomes

Complete response (CR)

Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

Time frame: 6 weeks

Time to response

The time from starting treatment to time of achievement of Response.

Time frame: 6 weeks

Bleeding events

The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.

Time frame: 6 weeks

Side Effects

Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .

Time frame: 6 weeks

Data from ClinicalTrials.gov

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