A Study of Orelabrutinib in Patients With ITP

NCT05124028 | Unknown Phase 1 DMC

• 1 other identifier: ZXH-ITP2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Immune Thrombocytopenia

Keywords

Bruton's Tyrosine Kinase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Complete response (CR)

  6 weeks

• Time to response

  6 weeks

• Bleeding events

  6 weeks

• Side effects

  6 weeks

Study Arms (1)

Orelabrutinib

EXPERIMENTAL

Orelabrutinib 50mg po qd 6 weeks

Drug: Orelabrutinib

Interventions

Orelabrutinib DRUG

50mg po qd 6 weeks

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:

• Confirmed primary refractory ITP
• Platelet counts \<30×10\^9/L or with bleeding symptoms
• Willing and able to sign written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

Location

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

• Xiao-Hui Zhang, MD

  Peking University Institute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Hui Zhang, MD

CONTACT

010-88324577; zhangxh100@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: November 17, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)