New China Clinical Trials with HGR Filing
On August 17, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from July 7, 2020 to July 20, 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/9425
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0339 | Prospective, multicenter, randomized, controlled clinical trial verifying the efficacy and safety of drug-eluting peripheral balloon dilatation catheters in initiating vertebral artery angioplasty | Xuanwu Hospital Capital Medical University | Acotec | 2020.07 |
| 2 | 2020BAL0340 | Blood glucose test paper clinical trial | Heping Hospital Affiliated to Changzhi Medical College | Jiangsu Shiungda Biotechnology Co. LTD | 2020.07 |
| 3 | 2020BAL0341 | Open, randomized, single oral administration and two-cycle crossover design were used to evaluate the bioequivalence of folodipine sustained-release tablets (Bofk ®, Changzhou Sifang Pharmaceutical Co., LTD.) and reference preparation (Bodipine ®, Astrazeneca Pharmaceuticals Co., LTD.) in healthy subjects in China | Shanghai Xuhui Central Hospital | Changzhou Siyao Pharmaceuticals Co.,Ltd. | 2020.07 |
| 4 | 2020BAL0342 | Assess TQB3473 in patients with recurrent or refractory malignant tumor blood safety, tolerability and pharmacokinetics of single arm, dose escalation phase I clinical research and extension | Henan Cancer Hospital | CTTQ | 2020.07 |
| 5
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2020BAL0343 | Randomized, open, controlled, exploratory phase II clinical trial of TQ-A3334 tablets combined with or without entecavir dispersible tablets for the injection of TQB2450 in patients with chronic hepatitis B | Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | CTTQ | 2020.07 |
| 6 | 2020BAL0344 | Clinical safety and efficacy of blood flow guide device for intracranial aneurysms | First Affiliated Hospital of Zhengzhou University | Beijing Jiushishenkang Medical Technology Co. LTD | 2020.07 |
| 7 | 2020BAL0345 | Study on bioequivalence of Esomeprazole Magnesium Enteric-dry Suspension in human (after meal) | Changsha Central Hospital | Kinderarznei | 2020.07 |
| 8 | 2020BAL0346 | Study on bioequivalence of Esomeprazole Magnesium Enteric-Dry Suspension in human (fasting) | Changsha Central Hospital | Kinderarznei | 2020.07 |
| 9 | 2020BAL0347 | Clinical evaluation of carbohydrate antigen 50 detection Kit (chemiluminescence) | Nantong Tumor Hospital | Sysmex | 2020.07 |
| 10 | 2020BAL0348 | Clinical evaluation of carbohydrate antigen 242 detection Kit (chemiluminescence) | Nantong Tumor Hospital | Sysmex | 2020.07 |
| 11 | 2020BAL0349 | Clinical evaluation of carbohydrate antigen 72-4 detection Kit (chemiluminescence) | Nantong Tumor Hospital | Sysmex | 2020.07 |
| 12 | 2020BAL0350 | Clinical evaluation of human epididymal protein 4 assay kit (chemiluminescence) | Nantong Tumor Hospital | Sysmex | 2020.07 |
| 13 | 2020BAL0351 | To evaluate phase I clinical trials of ASC41, a randomized, double-blind, placebo-controlled multi-dose, single-dose, multiple-dose, multiple-dose, safety, pharmacokinetic, and pharmacodynamic biomarker in healthy subjects | Hunan Provincial People’s Hospital | Ganlai Pharmaceutical Co. LTD | 2020.07 |
| 14 | 2020BAL0352 | Hepatitis C Virus Antibody Detection Kit (Chemiluminescence) | Beijing Tongren Hospital, Capital Medical University | Sysmex | 2020.07 |
| 15 | 2020BAL0353 | Open, randomized, single dose, totally four cycle repeatability crossover design, evaluation of fasting and postprandial state of valsartan capsule preparation subjects (fe ®, yongxin pharmaceutical industry (kunshan) co., LTD.) and the reference preparation (generation ®, Beijing novartis pharma co., LTD.) the bioequivalence trial in healthy subjects in China | Shanghai Xuhui Central Hospital | Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd | 2020.07 |
| 16 | 2020BAL0354 | Bioequivalence test of Spirosterone citrate tablets under fasting and postpranational conditions | The first Affiliated Hospital of Hunan Medical College | Creditpharma | 2020.07 |
| 17 | 2020BAL0355 | Trace protein Assay Kit (Turbidimetry) | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | Siemens | 2020.07 |
| 18 | 2020BAL0356 | A retrospective study on the efficacy of gefitinib tablets using the human EGFR mutant gene detection kit (multiple fluorescent PCR) | China-Japan Friendship Hospital | Amoydx | 2020.07 |
| 19 | 2020BAL0357 | Septin9 and NDRG4 gene methylation Detection kit (PCR fluorescent probe method) clinical trial | The People’s Hospital of Guangxi Zhuang Autonomous Region | Raybiotech | 2020.07 |
| 20 | 2020BAL0358 | Phase Ib clinical trial of TQB2450 injection combined with AL2846 capsule in patients with advanced hepatocellular carcinoma and gastric adenocarcinoma | Tianjin Medical University Cancer Hospital | CTTQ | 2020.07 |
| 21 | 2020BAL0359 | Clinical trial of sodium hyaluronate gel for ophthalmology | The Second Affiliated Hospital of Zhejiang University School of Medical | Eyebright | 2020.07 |
| 22 | 2020BAL0360 | Study on bioequivalence of Lakosamine tablets in human (pre-test) | Huaihua First People’s Hospital | Shanghai Pharma | 2020.07 |
| 23 | 2020BAL0361 | An extended study of Oraxol in patients with metastatic breast cancer | Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Athenex | 2020.07 |
| 24 | 2020BAL0362 | Clinical trial of electric tubular stapler | Shanxi Cancer Hospital | Suzhou Yingtukang Medical Technology Co., LTD | 2020.07 |
| 25 | 2020BAL0363 | A randomized, open, single-dose, two-dose, three-cycle, partially repeated cross-sectional bioequivalence trial of losartan potassium hydrochlorothiazide tablets in healthy subjects under fasting and post-pranational conditions | Yichang Central People’s Hospital | Suzhou Dawnrays Pharmaceutical Co.,Ltd. | 2020.07 |
| 26 | 2020BAL0364 | Human Immunodeficiency virus antigen and Antibody Detection Kit (Magnetic Particle chemiluminescence) | Beijing Tongren Hospital, Capital Medical University | Shanghai Ailex Technology Co.,Ltd. | 2020.07 |
| 27 | 2020BAL0365 | Clinical trials evaluating the availability of glucose monitoring systems | Yueyang Hospital of Integrative Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine | AscensiaChina | 2020.07 |
| 28 | 2020BAL0366 | TQB2450 injection combined with stereotactic radiotherapy in the treatment of advanced oligometastatic non-small cell lung cancer stage II clinical study | Peking University Third Hospital | CTTQ | 2020.07 |
| 29 | 2020BAL0367 | Amalian SF 24 Advanced Injectable Modified sodium hyaluronate gel for the safety and efficacy of nasolabial furrow correction a prospective, multi-center, randomized, single-blind, like-product controlled, non-inferiority clinical trial | Nanfang Hospital | Shenzhen Zhijun Pharmaceutical Co.,Ltd. | 2020.07 |
