A Study of Orelabrutinib in Patients With ITP

Immune Thrombocytopenia Clinical Trial

Official title:

A Study of Orelabrutinib in Patients With Primary Immune Thrombocytopenia (ITP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05124028
• Other study ID #: ZXH-ITP2021
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2021
• Source: Peking University People's Hospital
• Contact: Xiao-Hui Zhang, MD
• Phone: 010-88324577
• Email: zhangxh100[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Orelabrutinib
50mg po qd 6 weeks

Locations

Country	Name	City	State
China	Peking University Institute of Hematology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	Complete response (CR)	Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.	6 weeks
Secondary	Time to response	The time from starting treatment to time of achievement of Response.	6 weeks
Secondary	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.	6 weeks
Secondary	Side effects	Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .	6 weeks