A Study of Orelabrutinib in Patients With ITP | NCT05124028

Studies
A Study of Orelabrutinib in Patients With ITP

NCT05124028

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Nov 17, 2021Actual

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Immune Thrombocytopenia

Interventions

Orelabrutinib

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Jun 1, 2022Estimated

First Submitted Date

Nov 6, 2021

First Submission Date that Met QC Criteria

Nov 6, 2021

First Posted Date

Nov 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2021

Last Update Posted Date

Nov 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Hui Zhang, Clinical Professor, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orelabrutinib	Experimental	Orelabrutinib 50mg po qd 6 weeks	Drug: Orelabrutinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orelabrutinib	Drug	50mg po qd 6 weeks	Orelabrutinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Complete response (CR)	Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.	6 weeks
Time to response	The time from starting treatment to time of achievement of Response.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiao-Hui Zhang, MD	Contact	010-88324577		zhangxh100@sina.com

Overall Officials

Name	Affiliation	Role
Xiao-Hui Zhang, MD	Peking University Institute of Hematology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Institute of Hematology		Beijing	Beijing Municipality	100044	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000729508	orelabrutinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided