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

Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• Females of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days after the last administration of the investigational medicinal product (IMP).

Locations
Other Locations
China
Beijing CHAO-YANG Hospital Capital Medcal University
RECRUITING
Beijing
Peking university People's Hospital
NOT_YET_RECRUITING
Beijing
The first affiliated hospital of bengbu medical college
RECRUITING
Bengbu
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Chenzhou First People's Hospital
RECRUITING
Chenzhou
Xinqiao Hospital of Army Medical University
NOT_YET_RECRUITING
Chongqing
Qilu Hospital Of Shandong University Dezhou Hospital
NOT_YET_RECRUITING
Dezhou
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Provincial Hospital of Chinese Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Qilu hospital of shandong university
RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Gansu Provincial Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The Affilated Hospital of Southwest Medical University
NOT_YET_RECRUITING
Luzhou
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
The first Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Huazhong University of Science and Technology Union Shenzhen Hospital
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
North China University of Science and Technology Affiliated Hospital
NOT_YET_RECRUITING
Tangshan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Tongji Medical College Of Hust
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
Shaanxi Provincial People'S Hospital
RECRUITING
Xi’an
The First Affiliated Hospital of Xi 'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
Xi'an Central Hospital
RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Zhongshan Hospital Xiamen University
NOT_YET_RECRUITING
Xiamen
The Second People's Hospital of Yibin
NOT_YET_RECRUITING
Yibin
Yichang Central People's Hospital
RECRUITING
Yichang
The Central Hospital of Yongzhou
RECRUITING
Yongzhou
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Alexia Lu
CO_HGRAC@innocarepharma.com
010-66609745
Time Frame
Start Date: 2023-10-26
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 195
Treatments
Experimental: Orelabrutinib
Placebo_comparator: Placebo
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov

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