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A Study of Orelabrutinib in Patients With ITP

Primary Purpose

Immune Thrombocytopenia

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Orelabrutinib
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Bruton's Tyrosine Kinase

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Institute of Hematology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orelabrutinib

Arm Description

Orelabrutinib 50mg po qd 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2021
Last Updated
November 6, 2021
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05124028
Brief Title
A Study of Orelabrutinib in Patients With ITP
Official Title
A Study of Orelabrutinib in Patients With Primary Immune Thrombocytopenia (ITP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Bruton's Tyrosine Kinase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orelabrutinib
Arm Type
Experimental
Arm Description
Orelabrutinib 50mg po qd 6 weeks
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib
Intervention Description
50mg po qd 6 weeks
Primary Outcome Measure Information:
Title
Overall response (OR)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Complete response (CR)
Description
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Time Frame
6 weeks
Title
Time to response
Description
The time from starting treatment to time of achievement of Response.
Time Frame
6 weeks
Title
Bleeding events
Description
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.
Time Frame
6 weeks
Title
Side effects
Description
Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Hui Zhang, MD
Phone
010-88324577
Email
zhangxh100@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Hui Zhang, MD
Organizational Affiliation
Peking University Institute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Hematology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-Hui Zhang, MD
Phone
+86 13522338836
Email
zhangxh100@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of Orelabrutinib in Patients With ITP

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