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Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

Primary Purpose

Chronic Primary Immune Thrombocytopenia (ITP)

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Qrelabrutinib
Placebo
Sponsored by
Beijing InnoCare Pharma Tech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study. Males or females aged from 18 to 80 years (including the marginal values). With a body weight of ≥ 35 kg at screening. In accordance with the diagnosis of chronic (≥ 12 months) ITP Patients who have previously received at least one anti-ITP first-line standard treatment (glucocorticoids and/or intravenous immunoglobulin) cannot maintain efficacy, or relapse, or cannot tolerate standard treatment, or have insufficient response. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug. Exclusion Criteria: Severe hemorrhage occurred within 4 weeks prior to screening. Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator. Subjects had autoimmune systemic diseases other than ITP unless they would not affect the evaluation of the study results in the judgment of the investigator and sponsor medical monitor. Subjects had multiple immune hemocytopenia. Subjects had inherited thrombocytopenia or secondary ITP. Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening. Received prohibited medications within protocol-specified period before the first dose. Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug. Participated in another study of the investigational drug (and/or investigational device) within 30 days or within 5 half-lives prior to screening (whichever is longer), or is currently participating in another study of the investigational drug (and /or investigational device). The last administration of strong CYP3A inhibitors or strong CYP3A inducers (include food, western medicine, traditional Chinese medicine) is within 14 days (or 5 half-lives, whichever is longer) prior to the first dose, or planned to take a drug or food with a strong inhibition or induction of CYP3A during the study period. Received a major surgery (including splenectomy) or trauma (except biopsy) within 28 days prior to the first dose of the investigational drug, or expected to receive a major surgery during the study treatment period. Received splenectomy and had a prior history of overwhelming post-splenectomy infection (OPSI). Had a history of alcohol or drug abuse currently or within the past 1 year, excepting nicotine and caffeine. Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month prior to screening or during the screening period. Previous exposure to BTK inhibitors. Laboratory results did not meet protocol requirements. Pregnant or lactating women. Subjects whose blood cannot be collected, or who had contraindications for blood collection. Other conditions that were not appropriate for participation in the trial as considered by the investigators.

Sites / Locations

  • The first affiliated hospital of bengbu medical college
  • The First Affiliated Hospital of Anhui Medical University
  • Beijing CHAO-YANG Hospital Capital Medcal University
  • Nanfang Hospital, Southern Medical University
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Yichang Central People's Hospital
  • Jiangxi Provincial People's Hospital
  • The First Affiliated Hospital of Nanchang University
  • Qilu hospital of shandong university
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
  • The Second Affiliated Hospital of Kunming Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Orelabrutinib

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Durable response rate

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06004856
Brief Title
Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
Official Title
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients with Chronic Primary Immune Thrombocytopenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Primary Immune Thrombocytopenia (ITP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orelabrutinib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Qrelabrutinib
Intervention Description
Qrelabrutinib once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily (QD)
Primary Outcome Measure Information:
Title
Durable response rate
Time Frame
Throughout the study period, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study. Males or females aged from 18 to 80 years (including the marginal values). With a body weight of ≥ 35 kg at screening. In accordance with the diagnosis of chronic (≥ 12 months) ITP Patients who have previously received at least one anti-ITP first-line standard treatment (glucocorticoids and/or intravenous immunoglobulin) cannot maintain efficacy, or relapse, or cannot tolerate standard treatment, or have insufficient response. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug. Exclusion Criteria: Severe hemorrhage occurred within 4 weeks prior to screening. Subjects suffered from severe ITP at screening and were not eligible for participation in this study as judged by the investigator. Subjects had autoimmune systemic diseases other than ITP unless they would not affect the evaluation of the study results in the judgment of the investigator and sponsor medical monitor. Subjects had multiple immune hemocytopenia. Subjects had inherited thrombocytopenia or secondary ITP. Subjects had a history of arterial or venous thromboembolism within 6 months prior to screening. Received prohibited medications within protocol-specified period before the first dose. Received blood transfusion (including platelet transfusion) within 2 weeks prior to the first dose of the investigational drug. Participated in another study of the investigational drug (and/or investigational device) within 30 days or within 5 half-lives prior to screening (whichever is longer), or is currently participating in another study of the investigational drug (and /or investigational device). The last administration of strong CYP3A inhibitors or strong CYP3A inducers (include food, western medicine, traditional Chinese medicine) is within 14 days (or 5 half-lives, whichever is longer) prior to the first dose, or planned to take a drug or food with a strong inhibition or induction of CYP3A during the study period. Received a major surgery (including splenectomy) or trauma (except biopsy) within 28 days prior to the first dose of the investigational drug, or expected to receive a major surgery during the study treatment period. Received splenectomy and had a prior history of overwhelming post-splenectomy infection (OPSI). Had a history of alcohol or drug abuse currently or within the past 1 year, excepting nicotine and caffeine. Received a COVID-19 vaccine, live vaccine, or live-attenuated vaccine within 1 month prior to screening or during the screening period. Previous exposure to BTK inhibitors. Laboratory results did not meet protocol requirements. Pregnant or lactating women. Subjects whose blood cannot be collected, or who had contraindications for blood collection. Other conditions that were not appropriate for participation in the trial as considered by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexia Lu
Phone
010-66609745
Email
CO_HGRAC@innocarepharma.com
Facility Information:
Facility Name
The first affiliated hospital of bengbu medical college
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Zhang
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingshu Zeng
Facility Name
Beijing CHAO-YANG Hospital Capital Medcal University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenming Chen
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Sun
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Zhou
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Wang
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Mei
Facility Name
Yichang Central People's Hospital
City
Yichang
State/Province
Hubei
ZIP/Postal Code
443008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingming Guo
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenghao Jin
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruibin Huang
Facility Name
Qilu hospital of shandong university
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Hou, PhD
Phone
18560087007
Email
houming@medmail.com.cn
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmin Li
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang
Facility Name
The Second Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeping Zhou

12. IPD Sharing Statement

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Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Chronic Primary Immune Thrombocytopenia

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