Overview

A Study of Orelabrutinib in Patients With ITP

Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Orelabrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University People's Hospital
Criteria
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