New China Clinical Trials with HGR Filing
On September 26, 2020, Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from August 18, 2020 to September 4, 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/9478
http://www.cncbd.org.cn/Notice/Detail/9479
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New Clinical Trial Projects with Human Genetic Resources Filing
| No. | Filing Number | Project Name | Leading site | Sponsor | Filing Date |
| 1 | 2020BAL0433 | A clinical trial was conducted to evaluate the efficacy and safety of minimally invasive endoscopic surgery in urology for robot-assisted surgery | Changhai Hospital | MicroPort | 2020.08 |
| 2 | 2020BAL0434 | Clinical trial of human Immunodeficiency virus Type I (HIV-1) DNA Detection Kit (PCR-Fluorescent probe method) | Chinese Academy of Medical Sciences & Peking Union Medical College Hospital | SUPBIO | 2020.08 |
| 3 | 2020BAL0435 | A prospective, multicenter, randomized controlled clinical trial comparing the safety and efficacy of rapamycin – released coronary balloon catheter (SeQuent SCB) versus paclitaxel – released coronary artery balloon catheter (SeQuent Please Neo) in the treatment of in-stent restenosis of coronary arteries | General Hospital of Northern Theater Command | B. Braun Medical Inc. | 2020.08 |
| 4 | 2020BAL0436 | Clinical trial of fetal chromosome Aneuploidy (T21, T18, T13) Detection Kit (probe hybridization) | Women’s Hospital, School of Medicine, Zhejiang University (WHZJU) | Suzhou Sym-Bio Life Science Co.,Ltd. | 2020.08 |
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2020BAL0437 | Human AGTR1, ACE, ADRB1, CYP2D6, CYP2C9, CYP3A5 and NPPA gene Detection Kit (PCR-Fluorescent probe method) | Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China) | Wuhan Yzy Medical Science & Technology Co.,Ltd. | 2020.08 |
| 6 | 2020BAL0438 | Succinic acid to the nails rafa symplectic zyban fixed dose treatment of depression of multicenter, randomized, double blind and double simulation, duloxetine hydrochloride enteric capsules positive control Ⅲ phase of clinical trials | Beijing Tongren Hospital, Capital Medical University | CSPC | 2020.08 |
| 7 | 2020BAL0439 | Amalian SF 16 Sodium hyaluronate gel for Fine injection for the safety and efficacy of correcting nasolabial furrow wrinkles: a prospective, multicenter, randomized, single-blind, comparable, controlled, non-inferiority clinical trial | Plastic Surgery Hospital of Chinese Academy of Medical Sciences | Shenzhen Zhijun Pharmaceutical Co.,Ltd. | 2020.08 |
| 8 | 2020BAL0440 | Study on abnormal prothrombin reference interval in healthy Chinese population | Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University | Roche Diagnostics(Shanghai)Limited. | 2020.08 |
| 9 | 2020BAL0441 | Clinical trial of soluble growth stimulator expression gene 2 protein (ST2) Assay Kit (fluorescent immunodry quantitative method) | Ruikang Hospital affiliated to Guangxi University of Chinese Medicine | Boditech Med Inc. | 2020.08 |
| 10 | 2020BAL0442 | Bioequivalence of Caglinet tablets in healthy subjects in a randomized, open, two-dose, single-dose, double-cycle, double-cross fasting, and postpranational state | Dongguan Kanghua Hospital | Waterstone Pharmaceuticals(Hubei)Co.,Ltd. | 2020.08 |
| 11 | 2020BAL0443 | A multicenter, randomized, placebo parallel-controlled phase II/III trial to evaluate the clinical efficacy and safety of acetaminophen injection for postoperative analgesia with morphine | Tongji Hospital | Nanjing Kadixu Biological Engineering Technology Co.,Ltd.，Shanghai Industrial investment Holdings Co., Ltd. | 2020.08 |
| 12 | 2020BAL0444 | Combination Detection Kit for Human Immunodeficiency Virus Antigen and Antibody (Chemiluminescence immunoassay) | Beijing Tongren Hospital, Capital Medical University | DiaSorin Ltd. | 2020.08 |
| 13 | 2020BAL0446 | Trypsin 1 detection Kit (enzyme-linked immunoassay) | Changhai Hospital | BIOHIT Healthcare (Hefei) Co., Ltd. | 2020.08 |
| 14 | 2020BAL0445 | Hepatitis C Virus Antibody Detection Kit (Chemiluminescence) | Beijing Tongren Hospital, Capital Medical University | DiaSorin Ltd. | 2020.08 |
| 15 | 2020BAL0447 | A prospective, multicenter, randomized, parallel-controlled clinical trial to compare the efficacy and safety of drug-coated peripheral central venous catheter versus standard peripheral central venous catheter | Peking University People’s Hospital | Teleflex Medical Equipment Commercial Trade(Shanghai)Co.,Ltd. | 2020.08 |
| 16 | 2020BAL0448 | Procalcitonin assay Kit (Chemiluminescent microparticle immunoassay) | Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine | Abbott Laboratories Trading(Shanghai)Co.,Ltd. | 2020.08 |
| 17 | 2020BAL0449 | Whole blood platelet aggregation function detector | Beijing Tongren Hospital, Capital Medical University | Tashi biotechnology (Shanghai) Co., LTD. Tama Precision machine Co., LTD | 2020.08 |
| 18 | 2020BAL0450 | D-dimer Detection Kit (Latex immunoturbidimetry) | Hangzhou First People’s Hospital | Sekisui Medical Technology (China) LTD | 2020.08 |
| 19 | 2020BAL0451 | A prospective, randomized, parallel control, non-inferiority, double-center, open study of the efficacy and safety of 3D electronic sinus mirror in clinical use | First Affiliated Hospital of Sun yat-sen university | KARL STORZ Endoscopy (Shanghai) Ltd. | 2020.09 |
| 20 | 2020BAL0452 | Assessment reagent (light chain kappa test kit (immune turbidimetry) predominate light chain lambda detection kit (immune turbidimetry)) and contrast agent (igg kappa type light chain predominate assay kit (scattering turbidimetry) type immunoglobulin lambda light chain assay kit (scattering turbidimetry)) in the detection of serum samples kappa light chain and kappa/lambda predominate predominate ratio of consistency | Tongji Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.09 |
| 21 | 2020BAL0453 | Assessment reagent (light chain lambda test kit (immune turbidimetry) predominate light chain kappa detection kit (immune turbidimetry)) and contrast agent (igg lambda type light chain predominate assay kit (scattering turbidimetry) type immunoglobulin kappa light chain assay kit (scattering turbidimetry)) in the detection of serum samples lambda light chain and kappa/lambda predominate predominate ratio of consistency | Tongji Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.09 |
| 22 | 2020BAL0454 | An evaluation to evaluate reagent Lupus anticoagulant detection kit (solidification method) (English name: Lupus C) with Lupus anticoagulant detection kit (solidification method) (English name: Lupus S) Lupus anticoagulant content determination and comparison reagent kit (solidification method) (product English name: STA – Staclot DRVV) anticoagulant blood plasma samples of standardized testing people citrate salt ratio the consistency of comparison test | Tianjin Medical University Cancer Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.09 |
| 23 | 2020BAL0455 | An evaluation to evaluate reagent Lupus anticoagulant detection kit (solidification method) (English name: Lupus S) with Lupus anticoagulant detection kit (solidification method) (English name: Lupus C) Lupus anticoagulant content determination and comparison reagent kit (solidification method) (product English name: STA – Staclot DRVV) anticoagulant blood plasma samples of standardized testing people citrate salt ratio the consistency of comparison test | Tianjin Medical University Cancer Hospital | Roche Diagnostics(Shanghai)Limited. | 2020.09 |
| 24 | 2020BAL0456 | Aniline ibuprofen injection treatment, severe pain in the postoperative efficacy and safety of multicenter, randomized, double-blind, placebo parallel control III phase of clinical trials | The Third Xiangya Hospital of Central South University | Shijiazhuang Yiling Pharmaceutical Co., Ltd. | 2020.09 |
| 25 | 2020BAL0457 | Clinical trial of human immunodeficiency virus antigen antibody Diagnostic Kit (elisa) | Beijing Tongren Hospital, Capital Medical University | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | 2020.09 |
| 26 | 2020BAL0458 | Clinical study on the safety and efficacy of pigmented hydrophobic intraocular lens in cataract surgery | Tianjin Medical University Cancer Hospital | Zhengzhou Nestor Medical Technology Co. LTD | 2020.09 |
| 27 | 2020BAL0459 | A randomized, open, two-sequence, two-preparation, four-cycle, repeated-cross design bioequivalence trial of propofol fumarate tenofovir tablets administered orally and orally after fasting in healthy subjects | Hwa Mei Hospital, University of China Academy of Science | Suzhou Dawnrays Pharmaceutical Co.,Ltd. | 2020.09 |
| 28 | 2020BAL0460 | A prospective, multicentre, randomized controlled trial evaluating the safety and efficacy of tri-wire peripheral balloon dilatation catheter versus balloon dilatation catheter in the treatment of autologous arteriovenous fistula stenosis in hemodialysis patients | Peking University Third Hospital | Brosmed Medical | 2020.09 |
| 29 | 2020BAL0461 | A prospective, multicenter, randomized controlled clinical trial to verify the safety and efficacy of the Er:YAG laser therapy system for the treatment of mild to moderate stress incontinence | Beijing Hospital | Ou Zhixing (Suzhou) Medical Equipment Co. LTD | 2020.09 |
| 30 | 2020BAL0462 | A prospective, multicenter, randomized controlled clinical trial to evaluate the efficacy and safety of peripheral venous stent systems in the treatment of patients with iliac vein stenosis or occlusion | The First Affiliate Hospital of GUANGZHOU Medical University | Zhejiang Guichuang Medical Devices Co.,Ltd. | 2020.09 |
| 31 | 2020BAL0463 | A multicenter, randomized, double-blind, double-simulation, positive-drug parallel control phase III trial evaluating the efficacy and safety of salmeteroticasone inhaled powder in the treatment of adult bronchial asthma | China-Japan Friendship Hospital | Shanghai Oumini Medicine Technology Co.,Ltd，Suzhou Oumini Medicine Co.,Ltd. | 2020.09 |
