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