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BDB-001 Phase III Trial in ANCA-Associated Vasculitis
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Summary
The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab
Official title: A Multicenter, Randomized, Double-Blind, Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BDB-001 Injection in Patients With ANCA-Associated Vasculitis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-11-10
Completion Date
2028-02-29
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
BDB-001 injection
Intravenously administered
Cyclophosphamide
Intravenously administered
Rituximab
Intravenously administered
Azathioprine
Intravenously administered
Prednisone
Intravenously administered
Locations (50)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Shenzhen, Guangdong, China
Peking university Shenzhen Hospital
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region (gzar), China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Second Hospital of Hebei Medical University City:Shijiazhuang
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital,Tongji Medical college of Hust
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
General Hospital of Hunan University of Medicine
Changde, Hunan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University (Nephrology Department)
Changsha, Hunan, China
Xiangya Hospital Central South University(Rheumatism Immunity Branch)
Changsha, Hunan, China
General Hospital of Hunan University of Medicine
Huaihua, Hunan, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, China
Nanjing Gulou Hospital
Nanjing, Jiangsu, China
Nanjing University School of Medicine Affiliated Gulou Hospital
Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanbian, Jilin, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, China
Shandong Provincial Hospital
Jinan, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan hospital,Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xijing Hospital
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China