New China Clinical Trials with HGR Filing
On April 8, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from March 17, 2020 to March 30, 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/9237
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0147 | 2019-nCoV IgM/IgG antibody detection paper (colloidal gold method) | Hwa Mei Hospital, University of China Academy of Science | Zhejiang Orient Gene Biotech Co.,LTD | 2020.04 |
| 2 | 2020BAL0148 | 2019-nCoV nucleic acid detection reagent (fluorescence PCR method) | Hwa Mei Hospital, University of China Academy of Science | Zhejiang Orient Gene Biotech Co.,LTD | 2020.04 |
| 3 | 2020BAL0150 | Clinical study of Precision1TM soft contact lens | Eye Hospital, WMU Zhejiang Eye Hospital | Alcon Research, LLC. | 2020.04 |
| 4 | 2020BAL0153 | Clinical study on the first-line treatment of squamous non-small cell lung cancer with anrotidine hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy | Cancer Hospital Chinese Academy of Medical Science | Chiatai Tianqing | 2020.04 |
| 5 | 2020BAL0154 | A multicentre, randomized, double-blind, three-arm, parallel clinical study evaluated the clinical end-point bioequivalence of two budesonide nasal sprays in subjects with seasonal allergic rhinitis | Beijing Tongren Hospital, Capital Medical University | Nanchang Baiji Medicine Technology Co.,Ltd. | 2020.04 |
| 6 | 2020BAL0159 | Clinical trial of PD-l1 antibody reagent (immunohistochemistry) | Henan Cancer Hospital | Suzhou Yaoming Zekang | 2020.04 |
| 7 | 2020BAL0164 | Bioequivalence of tizanidine hydrochloride tablets in human subjects under fasting and postprandial conditions | Yiyang Central Hospital | Sichuan Credit Pharmaceutical Co., Ltd | 2020.04 |
| 8 | 2020BAL0166 | D-dimer detection kit (immunoturbidimetry) | Emergency General Hospital | SYSMEX CORPORATION | 2020.04 |
| 9 | 2020BAL0167 | Fibrin/fibrinogen degradation product determination kit (immunoturbidimetry) | Emergency General Hospital | SYSMEX CORPORATION | 2020.04 |
| 10 | 2020BAL0170 | A prospective, multicenter, randomized, non-inferiority clinical study to evaluate the safety and effectiveness of VasolineTM in clinical application | Beijing Anzhen Hospital, Capital Medical University | Jiangsu Bioda Life Science | 2020.04 |
| 11 | 2020BAL0182 | A phase 3 randomized study evaluating the safety and antiviral activity of Remdesivir (gs-5734tm) in the treatment of severe COVID-19 study participants | The First Affiliate Hospital of GUANGZHOU Medical University | Gilead Sciences, Inc. | 2020.04 |
| 12 | 2020BAL0183 | A randomized phase 3 study comparing the safety and antiviral activity of Remdesivir gs-5734tm with standard care therapy for the treatment of moderate COVID-19 study participants | The First Affiliate Hospital of GUANGZHOU Medical University | Gilead Sciences, Inc. | 2020.04 |
| 13 | 2020BAL0184 | Effectiveness and safety of xenon therapy for insomnia | Shanghai Mental Health Center | Zhejiang Xianke | 2020.04 |
| 14 | 2020BAL0185 | Clinical trial of SARS-CoV-2 IgG antibody detection kit (chemiluminescence immunoassay) | Zhongnan Hospital of Wuhan University | Mindray | 2020.04 |
| 15 | 2020BAL0186 | Clinical trial of SARS-CoV-2 IgM antibody detection kit (chemiluminescence immunoassay) | Zhongnan Hospital of Wuhan University | Mindray | 2020.04 |
