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

NCT05020288 | Unknown Phase 2 DMC

• 1 other identifier: ITP-Orelabrutinib
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Thrombocytopenia; Bruton's Tyrosine Kinase

Keywords

Orelabrutinib

Outcome Measures

Primary Outcomes (2)

• Initial overall response to Orelabrutinib

  Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.

  14 days after the first dose of Orelabrutinib

• Sustained overall response to Orelabrutinib

  Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.

  A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response

Secondary Outcomes (3)

• Time to response

  An average of 6 months

• Duration of response

  through study completion, an average of 1 year

• Therapy associated adverse events

  Up to 1 year

Study Arms (1)

Orelabrutinib

EXPERIMENTAL

Orelabrutinib 50mg po qd

Drug: Orelabrutinib

Interventions

Orelabrutinib DRUG

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

Also known as: ICP-022

Orelabrutinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shandong University: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

orelabrutinib

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ming Hou, MD,PhD

  Shandong University Qilu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, MD,PhD

CONTACT

0531-82169879; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 25, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: August 25, 2021

Record last verified: 2021-08