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| Name | Class |
|---|---|
| Shanghai Pharmaceuticals Holding Co., Ltd | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of B007 in subjects with generalized myasthenia gravis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B007 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B007 | Drug | B007 high dose and low dose: Subcutaneous injection was administered on days 1 and 15 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by ≥2 | Proportion of subjects:MG-ADL decreased by ≥2 | Approximately 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects:subjects without SoC(Standard of Care) change and MG-ADL decreased by ≥2 | Proportion of subjects:subjects without SoC change and MG-ADL decreased by ≥2 | Approximately 24 weeks |
| Proportion of subjects:subjects without SoC change and QMG(Quantitative Myasthenia Gravis score) decreased by ≥3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianying Xi | Contact | 0086-021-52888045 | hsyybwc@163.com | |
| Huan Yang | Contact | 0086-0731-84327919 | xyyyllwyh@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | China |
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| Placebo |
| Drug |
B007 matched Placebo Subcutaneous injection was administered on days 1 and 15 |
|
Proportion of subjects:subjects without SoC change and QMG decreased by ≥3 |
| Approximately 24 weeks |
| Changes in MGQoL15r (Myasthenia gravis quality of life15-item revised) from baseline. | Changes in MGQoL15r from baseline. | Approximately 24 weeks |
| Changes in MGC (Myasthenia gravis composite) from baseline. | Changes in MGC from baseline | Approximately 24 weeks |
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration | Approximately 1 years |
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | China |
|
| Xiangya Hospital Central South University | Recruiting | Changsha | China |
|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | China |
|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
|
| Shandong Provincial Qianfoshan Hospital | Recruiting | Jinan | China |
|
| Shandong University Cheeloo College of Medicine | Recruiting | Jinan | China |
|
| First People's Hospital of Yunnan Province | Recruiting | Kunming | China |
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| Jiangxi Provincial People's Hospital | Recruiting | Nanchang | China |
|
| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
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| Shandong University Cheeloo College of Medicine | Recruiting | Qingdao | China |
|
| Huashan Hospital, Fudan University | Recruiting | Shanghai | China |
|
| Shenzhen Hospital of University of Hong Kong | Recruiting | Shenzhen | China |
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| Renmin Hospital of Wuhan University | Recruiting | Wuhan | China |
|
| Tongji Medical College of HUST | Recruiting | Wuhan | China |
|
| Tangdu Hospital | Recruiting | Xi'an | China |
|
| Affiliated Hospital of Zunyi Medical College | Recruiting | Zunyi | China |
|
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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