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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BDB-001 injection group | Experimental | BDB-001 injection plus cyclophosphamide/azathioprine or rituximab plus prednisone-matching placebo. |
|
| Prednisone group | Active Comparator | BDB-001 injection-matching placebo plus cyclophosphamide/azathioprine or rituximab plus a full starting dose of prednisone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BDB-001 injection | Drug | Intravenously administered |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving disease remission assessed by Birmingham Vasculitis Activity Score (BVAS) | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving disease sustained remission assessed by Birmingham Vasculitis Activity Score (BVAS) | Week 48 | |
| Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission in the Study | Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Sun | Contact | +86 010-67519614 | sunaiping@staidson.com |
| Name | Affiliation | Role |
|---|---|---|
| Minghui Zhao, M.D. | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100005 | China |
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| Cyclophosphamide |
| Drug |
Intravenously administered |
|
| Rituximab | Biological | Intravenously administered |
|
| Azathioprine | Drug | Intravenously administered |
|
| Prednisone | Drug | Intravenously administered |
|
| Percentage of Participants With BVAS of 0 at Week 4 | Week 4 |
| In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Estimated glomerular filtration rate (eGFR) | Baseline, Week 24 and Week 48 |
| In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), Change from baseline in Urinary albumin:creatinine ratio (UACR) | Baseline, Week 4, 24 and 48 |
| Glucocorticoid-induced Toxicity as Measured by Change From Baseline in the GTI | Baseline, Week 24 and 48 |
| Cumulative dose of glucocorticoids | Week 24 and 48 |
| Change from baseline in the Vasculitis Damage Index (VDI) | Baseline, Week 24 and 48 |
| Change From Baseline in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36 | Baseline, Week 24 and 48 |
| Peking University People's Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
|
| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Peking University International Hospital | Not yet recruiting | Beijing | Beijing Municipality | 102206 | China |
|
| Beijing Tsinghua Changgung Hospital | Not yet recruiting | Beijing | Beijing Municipality | 102218 | China |
|
| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 710000 | China |
|
| The Second Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400016 | China |
|
| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361003 | China |
|
| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
|
| Guangdong General Hospital | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
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| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Meizhou People's Hospital | Not yet recruiting | Meizhou | Guangdong | 514031 | China |
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| Yuebei People's Hospital | Not yet recruiting | Shaoguan | Guangdong | 512026 | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Shenzhen | Guangdong | 510080 | China |
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| Peking university Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518036 | China |
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| Liuzhou People's Hospital | Not yet recruiting | Liuzhou | Guangxi | 545006 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Guangxi Academy of Medical Sciences,The People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Nanning | Guangxi Zhuang Autonomous Region (gzar) | 530016 | China |
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| Guizhou Provincial People's Hospital | Not yet recruiting | Guiyang | Guizhou | 550002 | China |
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| Cangzhou City People's Hospital | Not yet recruiting | Cangzhou | Hebei | 061000 | China |
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| The Second Hospital of Hebei Medical University City:Shijiazhuang | Not yet recruiting | Shijiazhuang | Hebei | 050004 | China |
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| Kailuan General Hospital | Not yet recruiting | Tangshan | Hebei | 063000 | China |
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| The Second Affiliated Hospital of Harbin | Not yet recruiting | Harbin | Heilongjiang | 150086 | China |
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| The First Affiliated Hospital of Henan University of science and Technology | Not yet recruiting | Luoyang | Henan | 471003 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Tongji Hospital,Tongji Medical college of Hust | Not yet recruiting | Wuhan | Hubei | 100005 | China |
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| Yichang Central People's Hospital | Not yet recruiting | Yichang | Hubei | 443003 | China |
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| General Hospital of Hunan University of Medicine | Not yet recruiting | Changde | Hunan | 415000 | China |
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| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410005 | China |
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| Xiangya Hospital Central South University (Nephrology Department) | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| Xiangya Hospital Central South University(Rheumatism Immunity Branch) | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| General Hospital of Hunan University of Medicine | Not yet recruiting | Huaihua | Hunan | 418000 | China |
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| Zhuzhou Central Hospital | Not yet recruiting | Zhuzhou | Hunan | 412007 | China |
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| Nanjing Gulou Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing University School of Medicine Affiliated Gulou Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | 221002 | China |
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| Jiangxi Provincial People's Hospital | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The Second Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130041 | China |
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| Affiliated Hospital of Yanbian University (Yanbian Hospital) | Not yet recruiting | Yanbian | Jilin | 133000 | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shengyang | Liaoning | 110004 | China |
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| Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Neimenggu | 010050 | China |
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| Shandong Provincial Hospital | Not yet recruiting | Jinan | Shandong | 250021 | China |
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| Weifang People's Hospital | Not yet recruiting | Weifang | Shandong | 261041 | China |
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| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Zhongshan hospital,Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
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| The Second Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
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| Xijing Hospital | Not yet recruiting | Xi’an | Shanxi | 710032 | China |
|
| The First Affiliated Hospital of Xi'an Jiao Tong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830054 | China |
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| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | Yunnan | 650032 | China |
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| The First Affiliated Hospital, College of Medicine, Zhejiang University | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
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| The Second Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310014 | China |
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| People's Hospital of Lishui | Not yet recruiting | Lishui | Zhejiang | 323000 | China |
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| The Affiliated Hospital of the Medical School of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315010 | China |
|
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000719787 | BDB001 |
| D003520 | Cyclophosphamide |
| D000069283 | Rituximab |
| D001379 | Azathioprine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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