A Study of Orelabrutinib in Patients With ITP

Sponsor

Peking University People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05124028

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Drug: Orelabrutinib	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study of Orelabrutinib in Patients With Primary Immune Thrombocytopenia (ITP)

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orelabrutinib Orelabrutinib 50mg po qd 6 weeks	Drug: Orelabrutinib 50mg po qd 6 weeks

Arm

Intervention/Treatment

Experimental: Orelabrutinib

Orelabrutinib 50mg po qd 6 weeks

Drug: Orelabrutinib

50mg po qd 6 weeks

Outcome Measures

Primary Outcome Measures

Overall response (OR) [6 weeks]
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) [6 weeks]
Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.
Time to response [6 weeks]
The time from starting treatment to time of achievement of Response.
Bleeding events [6 weeks]
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 [6 weeks]
Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Institute of Hematology	Beijing	Beijing	China	100044

Sponsors and Collaborators

Peking University People's Hospital

Investigators

Principal Investigator: Xiao-Hui Zhang, MD, Peking University Institute of Hematology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiao Hui Zhang, Clinical Professor, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05124028

Other Study ID Numbers:

ZXH-ITP2021

First Posted:

Nov 17, 2021

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiao Hui Zhang, Clinical Professor, Peking University People's Hospital

Bruton's Tyrosine Kinase

Additional relevant MeSH terms:

Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Study Results

No Results Posted as of Nov 17, 2021