A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP

NCT ID: NCT05020288

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-06-01

Brief Summary

BTK participates in a variety of signal transduction of innate and adaptive immunity, and has an important role in cell proliferation, differentiation and apoptosis. The impact of BTK inhibitors on hematological malignancies and autoimmune diseases has been well studied. This project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of the selective BTK inhibitor Orelabrutinib in the management of refractory ITP.

Detailed Description

The investigators are undertaking a prospective, open-lable, multicentre trial of 40 refractory ITP adult patients in China. Eligible participants will receive Orelabrutinib in 50 mg po. qd, every 4 weeks for one cycle and it will be given 3 cycles. For non-responders who were well tolerated at 12 weeks of follow-up, the treatment could be extended to 6 cycles. The treatment will be discontinued after 6 months without blood index reaction. In order to report the efficacy and safety of Orelabrutinib in the management of refractory ITP, platelet count, bleeding and other symptoms will be evaluated before and after treatments. Adverse events are also recorded throughout the study.

Conditions

Immune Thrombocytopenia; Bruton's Tyrosine Kinase

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orelabrutinib

Orelabrutinib 50mg po qd

Group Type: EXPERIMENTAL

Orelabrutinib

Intervention Type: DRUG

Orelabrutinib 50mg po qd, every four weeks for one cycle. It will be given three cycles.

Interventions

Orelabrutinib

Orelabrutinib 50mg po qd, every four weeks for one cycle. It will be given three cycles.

Intervention Type: DRUG

Other Intervention Names

ICP-022

Eligibility Criteria

Inclusion Criteria

• Meet the diagnostic criteria for primary immune thrombocytopenia
• To show a platelet count < 30 * 10^9/L, or with bleeding manifestations, or both
• Willing and able to sign written informed consent
• Meet the diagnostic criteria of refractory ITP according to Chinese guidelines

Exclusion Criteria

• Secondary thrombocytopenia
• severe immune-deficiency or history of primary immunodeficiency
• active or previous malignancy
• HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess)
• pregnancy or lactation
• diabetes
• hypertension
• cardiovascular diseases
• severe liver or kidney function impairment
• psychosis
• osteoporosis
• inflammatory bowel disease or gastric disease
• arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment
• an organ or haematopoietic stem-cell transplantation
• neutrophil count of less than 1500 cells per mm³; glycosylated haemoglobin less than 8%; partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN)
• clinical electrocardiogram changes
• neoplastic disease within the past 5 years
• corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
• substance misuse within the previous 12 months; and those who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu Hospital

Central Contacts

Ming Hou, MD,PhD

Role: CONTACT

houming@medmail.com.cn

0531-82169879

Other Identifiers

ITP-Orelabrutinib

Identifier Type: -

Identifier Source: org_study_id