A Study of Orelabrutinib in Patients With ITP

Peking University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Immune Thrombocytopenia

Treatments: Drug: Orelabrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05124028

ZXH-ITP2021

Details and patient eligibility

About

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).

Full description

The investigators are undertaking a prospective trial of 10 adults with ITP in China. Orelabrutinib is administered as 50 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Orelabrutinib

Experimental group

Description:

Orelabrutinib 50mg po qd 6 weeks

Treatment:

Drug: Orelabrutinib