New China Clinical Trials with HGR Filing
On July 29, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from June 9, 2020 to July 6, 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/9372
http://www.cncbd.org.cn/Notice/Detail/9366
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0297 | Calcitonin assay Kit (Chemiluminescence) | Xuzhou Central Hospital | Siemens | 2020.07 |
| 2 | 2020BAL0298 | Erythropoietin assay Kit (Chemiluminescence) | Xuzhou Central Hospital | Siemens | 2020.07 |
| 3 | 2020BAL0299 | Assay kit for Antithyroglobulin Antibody (Chemiluminescence) | Xuzhou Central Hospital | Siemens | 2020.07 |
| 4 | 2020BAL0300 | Clinical trials on the safety and efficacy of TianXinFu oral biofilm for alveolar ridge preservation after tooth extraction surgery | Peking University Hospital of Stomatology | Beijing TianXinFu Medical Appliance Co., Ltd | 2020.07 |
| 5
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2020BAL0301 | A clinical trial was conducted to evaluate the efficacy and safety of MicroPort® endoscopic surgery in urology for robot-assisted surgery | Changhai Hospital | MicroPort | 2020.07 |
| 6 | 2020BAL0302 | Clinical trial of influenza A/B Virus Nucleic Acid Detection Kit (Closed PCR chromatography) (Protocol No.: MESa-flu-01) | Peking University First Hospital | Hai Mei Kang Ji | 2020.07 |
| 7 | 2020BAL0303 | Portable fully automatic Temperature Controller for Nucleic Acid Amplification (DOCK) (Program No.: Mesa-Dock-01) | Peking University First Hospital | Hai Mei Kang Ji | 2020.07 |
| 8 | 2020BAL0304 | A randomized, parallel, controlled phase I trial of deoxycholic acid injection for submental fat layer injection in a Chinese population with submental fat accumulation | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | NoraTech | 2020.07 |
| 9 | 2020BAL0305 | A prospective, multicenter, randomized, double-blind, point-of-care clinical study evaluated the efficacy and safety of injectable modified sodium hyaluronate gel for the correction of moderate or severe nasolabial furrow and pain reduction | Shanghai Ninth People’s Hospital | Keyan Biological Technology Co., LTD., Cheng Ze Medical Equipment (Shanghai) Co., LTD | 2020.07 |
| 10 | 2020BAL0306 | Clinical trial on safety and efficacy of TranseeTM atrial septal puncture system | Changhai Hospital | PushMed | 2020.07 |
| 11 | 2020BAL0307 | A randomized, open, positive drug parallel-controlled multicenter trial of inhaled budesonide suspension for treatment of bronchial asthma in mild to moderate acute exacerbations | The First Affiliate Hospital of GUANGZHOU Medical University | CTTQ | 2020.07 |
| 12 | 2020BAL0308 | A prospective, multicenter, open, single-group target clinical trial to evaluate the safety and efficacy of thrombus aspiration catheters in the treatment of acute ischemic stroke | Xuanwu Hospital Capital Medical University | Suzhou Zenith Vascular Scitech Limited | 2020.07 |
| 13 | 2020BAL0309 | Single-arm, multicenter Phase II clinical Trial of TQ-B3525 for recurrent/refractory mantle cell lymphoma (MCL) | Jiangsu Cancer Hospital | CTTQ | 2020.07 |
| 14 | 2020BAL0310 | Safety and efficacy of intracranial thrombotomy devices for intravascular treatment of acute ischemic stroke (prospective, multicenter, open-label, end-point blind, stratified randomized, parallel positive control, non-inferiority test clinical trial) | The First Affiliated Hospital of Harbin Medical University | HEMO | 2020.07 |
| 15 | 2020BAL0311 | A phase II clinical trial of Annaotriol Injection in the treatment of cerebral apoplexy after glioma surgery — single-center, single-arm open trial | Sun Yat-sen University Cancer Center (SYSUCC) | CellProTech | 2020.07 |
| 16 | 2020BAL0312 | Cholesterol dipstick clinical trial | Heping Hospital Affiliated to Changzhi Medical College | Jiangsu Shiungda Biotechnology Co. LTD | 2020.07 |
| 17 | 2020BAL0313 | Uric acid test paper clinical trial | Heping Hospital Affiliated to Changzhi Medical College | Jiangsu Shiungda Biotechnology Co. LTD | 2020.07 |
| 18 | 2020BAL0314 | TQ05510 capsule different doses, single-center, randomized, double-blind, placebo-controlled phase I b in the treatment of type 2 diabetes clinical research | Affiliated Hospital of Changchun University of Chinese Medicine | CTTQ | 2020.07 |
| 19 | 2020BAL0315 | Novel Coronavirus (SARS-COV-2) Antibody Detection Kit (Electroluminescence) (Elecsys Anti-SARS-CoV-2) Clinical Trial | Shanghai Public Health Clinical Center | Roche Diagnostics (Shanghai)Limited. | 2020.07 |
| 20 | 2020BAL0316 | Comparative study on pharmacokinetics of Bismuth potassium citrate tablets in human | Changsha Central Hospital | LivZon | 2020.07 |
| 21 | 2020BAL0317 | Novel CoronavirUS2019-NCOV Nucleic acid Detection Kit (FLUORESCENCE PCR) Clinical trial | Chengdu Public Health Clinical Medical Center | Amoydx | 2020.07 |
| 22 | 2020BAL0318 | Evaluation of cyclosporine assay kit methodology | First Affiliated Hospital of Zhengzhou University | Suzhou Pharmaceutical Mingzekang Biological Technology Co. LTD | 2020.07 |
| 23 | 2020BAL0319 | To verify the efficacy and safety of the SaExten® vena cava filter system in the prevention of pulmonary embolism in a multicentre, randomized, positive controlled clinical study | First Affiliated Hospital of Sun yat-sen university | Shenzhen Kyd Biomedical Technology Co., Ltd. | 2020.07 |
| 24 | 2020BAL0320 | Clinical evaluation of prolactin detection Kit (electrochemical luminescence method) | Changzhou NO.2 People’s Hospital | Roche Diagnostics (Suzhou,Shanghai)Limited. | 2020.07 |
| 25 | 2020BAL0321 | Clinical evaluation of estradiol Detection Kit (Electrochemical luminescence method) | Changzhou NO.2 People’s Hospital | Roche Diagnostics (Suzhou,Shanghai)Limited. | 2020.07 |
| 26 | 2020BAL0322 | Clinical evaluation of triglyceride detection kit (colorimetric method) | Changzhou NO.2 People’s Hospital | Roche Diagnostics (Suzhou,Shanghai)Limited. | 2020.07 |
| 27 | 2020BAL0323 | CM082 tablets were randomized, open, two-dose, single-dose, two-cycle, double-cross fasting, and post pranational bioequivalence in healthy subjects | The Second Affiliated Hospital of Zhejiang University School of Medical | Kananji Medicine Technology (Shanghai)Co.,Ltd. | 2020.07 |
| 28 | 2020BAL0325 | Evaluate the application of intervertebral fusion device in posterior spinal surgery for lower lumbar intervertebral disc and vertebral degeneration; Prospective, multicenter, randomized, parallel-controlled, noninferiority clinical trial of the safety and efficacy of spinal fusion involving spinal instability, neuropore space stenosis, or pseudoarthropathy | First Affiliated Hospital of Zhengzhou University | DragonCrown | 2020.07 |
| 29 | 2020BAL0326 | Clinical trial of influenza A/B Virus Nucleic Acid Detection Kit (Closed PCR chromatography) (Protocol No.: MESa-flu-01) | Peking University First Hospital | Hai Mei Kang Ji | 2020.07 |
| 30 | 2020BAL0327 | Portable fully automatic Temperature Controller for Nucleic Acid Amplification (DOCK) (Program No.: Mesa-Dock-01) | Peking University First Hospital | Hai Mei Kang Ji | 2020.07 |
| 31 | 2020BAL0328 | Determination of antithrombin III kit (send lubricious substrate method) | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Sysmex | 2020.07 |
| 32 | 2020BAL0329 | Evaluate the efficacy and safety of NS-126Z in the treatment of seasonal allergic rhinitis in a multicenter, randomized, double-blind, parallel, placebo-controlled phase III trial | Beijing Tongren Hospital, Capital Medical University | Nippon Shinyaku Co Ltd | 2020.07 |
| 33 | 2020BAL0330 | Clinical evaluation of C-peptide Detection Kit (electrochemical luminescence method) | The Second Hospital Affiliated to Suzhou University | Roche Diagnostics (Suzhou,Shanghai)Limited. | 2020.07 |
| 34 | 2020BAL0331 | Clinical trial of bicarbonate Detection Kit (Colorimetric method) | The Second Hospital Affiliated to Suzhou University | Roche Diagnostics (Suzhou,Shanghai)Limited. | 2020.07 |
| 35 | 2020BAL0332 | Clinical trial of human IDH1/IDH2 mutant gene combined detection Kit (FLUORESCENCE PCR method) | Fujian Medical University Union Hospital | Amoydx | 2020.07 |
| 36 | 2020BAL0333 | A multicenter, randomized, evaluator blind, treatment-free controlled clinical trial to evaluate the efficacy and safety of YVOIRE Y-Solution 720 for midface injection filling | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | LG Chem, Ltd. | 2020.07 |
| 37 | 2020BAL0334 | A randomized, single-blind, positive parallel controlled trial on the efficacy and safety of a prefilled catheter irrigator for sealing and flushing the end of catheter lines | The Second Affiliated Hospital of Nanjing Medical University | Shanghai Blood Transfusion Technology Co.,Ltd. | 2020.07 |
| 38 | 2020BAL0335 | Prefilled catheter flusher is a multicenter, randomized, single-blind, positive parallel controlled clinical trial for the efficacy and safety of PICC catheter sealing and flushing catheter end | The Second Affiliated Hospital of Nanjing Medical University | Shanghai Blood Transfusion Technology Co.,Ltd. | 2020.07 |
| 39 | 2020BAL0336 | Prospective, randomized, controlled, single-blind, multicenter, noninferiority clinical trial evaluating the efficacy and safety of spinal cement in the treatment of vertebral compression fractures | Tongji Hospital | Shanghai Yijiutai Medical Technology Co., LTD | 2020.07 |
| 40 | 2020BAL0337 | The safety and efficacy of the hollow fiber dialyzer Rexled-18MC in hemodialysis treatment | The First Affiliated Hospital of Medical School of Zhejiang University | Asahi Kasei | 2020.07 |
