New China Clinical Trials with HGR Filing
On March 24, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from March 3, 2020 to March 16, 2020 on human genetic resources in China. As per China GCP Regulation, clinical trial must obtain the HGR filing before official conduction.
Link: http://www.cncbd.org.cn/Notice/Detail/9227
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0101 | A prospective, multi-center, single-group target value clinical trial to evaluate the safety and effectiveness of the suction catheter system for endovascular treatment in patients with acute ischemic stroke. | Xuanwu Hospital Capital Medical University | Shanghai Wobi Medical Technology Co., Ltd. | 2020.03 |
| 2 | 2020BAL0103 | Clinical trial of SIGNA Prime medical magnetic resonance imaging system | Shanghai 6th People’s Hospital | GE Healthcare | 2020.03 |
| 3 | 2020BAL0105 | Exploring clinical trials of pharmacokinetics and safety of recombinant humanized anti-VEGF monoclonal antibody (JY028) injection in healthy subjects | Xuanwu Hospital Capital Medical University | Eastern Biotech | 2020.03 |
| 4 | 2020BAL0106 | Exploratory clinical trials of pharmacokinetics and safety of recombinant anti-tumor necrosis factor-α fully human monoclonal antibody (JY026) injection in healthy subjects | Xuanwu Hospital Capital Medical University | Eastern Biotech | 2020.03 |
| 5 | 2020BAL0112 | Human immunodeficiency virus antigen and antibody combined assay reagent (chemiluminescence method) | Beijing YouAn Hospital, Capital Medical University | Siemens | 2020.03 |
| 6 | 2020BAL0113 | Multicenter randomized controlled trial of high intensity focused ultrasound (HIFU) in the treatment of benign thyroid nodules | Guangdong Provincial People’s Hospital | Theraclion | 2020.03 |
