New China Clinical Trials with HGR Filing

2020-03-20

Human Genetic Resources (HGR) Office has publicized the filing status of international collaborative clinical trials, which are filed from February 18, 2020 to March 2, 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/9212

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New Clinical Trial Projects with Human Genetic Resources Filing

No.	Filing Number	Project Name	Leading site	Sponsor	Filing Date
1	2020BAL0080	Clinical trial of the safety and effectiveness of spiral catheter integrated membrane oxygenator in cardiopulmonary bypass cardiac surgery — multicenter, randomized, single-blind, positive, parallel-controlled clinical trial	Beijing Anzhen Hospital, Capital Medical University	MiroPort	2020.03
2	2020BAL0093	Efficiency and safety of ADASUVE in the acute control of agitation in adults with schizophrenia or bipolar disorder in a randomized, double-blind, placebo-controlled, multicenter clinical study	Beijing Anding Hospital, Capital Medical University	Zhaoke Pharmaceutical(Hefei)Co.,Ltd.	2020.03
3	2020BAL0094	A multicenter, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficiency and safety of Favipiravir in the treatment of hospitalized adults with novel coronavirus common pneumonia	The First Affiliated Hospital of Medical School of Zhejiang University	ZHEJIANG HISUN PHARMACEUTICAL CO.,LTD	2020.03