A Study of Orelabrutinib in Patients With ITP

Phase 1

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Orelabrutinib

• Registration Number: NCT05124028
• Lead Sponsor: Peking University People's Hospital

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-06
• Study First Submitted QC: 2021-11-06
• Last Update Submitted: 2021-11-06
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17
• Study Start: 2021-12-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orelabrutinib	Orelabrutinib	Orelabrutinib 50mg po qd 6 weeks

Primary Outcome Measures

Name	Time	Method
Overall response (OR)	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Side effects	6 weeks	Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .
Complete response (CR)	6 weeks	Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Time to response	6 weeks	The time from starting treatment to time of achievement of Response.
Bleeding events	6 weeks	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.

Trial Locations

Locations (1)

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China