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A Study of Orelabrutinib in Patients With ITP

NCT ID: NCT05124028

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Immune Thrombocytopenia

Keywords

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Bruton's Tyrosine Kinase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orelabrutinib

Orelabrutinib 50mg po qd 6 weeks

Group Type EXPERIMENTAL

Orelabrutinib

Intervention Type DRUG

50mg po qd 6 weeks

Interventions

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Orelabrutinib

50mg po qd 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao Hui Zhang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Hematology

Locations

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Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiao-Hui Zhang, MD

Role: CONTACT

Phone: 010-88324577

Email: [email protected]

Facility Contacts

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Xiao-Hui Zhang, MD

Role: primary

Other Identifiers

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ZXH-ITP2021

Identifier Type: -

Identifier Source: org_study_id