[Translation] A randomized double-blind comparative study on the efficacy and safety of recombinant batroxobin for injection in hemostasis of posterior lumbar interbody fusion

进行重组巴曲酶的I~II期临床试验，确定重组巴曲酶的有效性和安全性后，申请III期临床试验批件。

[Translation]

Conduct Phase I and II clinical trials of recombinant batroxobin, and after determining the effectiveness and safety of recombinant batroxobin, apply for Phase III clinical trial approval.

Start Date-

Sponsor / Collaborator-

CTR20202352 / Active, not recruitingPhase 3

评估重组巴曲酶在颈椎后路手术与腰椎后路椎间融合术受试者中止血治疗的疗效和安全性的多中心、随机、双盲、安慰剂对照III期临床研究

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of recombinant batroxobin in hemostatic treatment in subjects undergoing posterior cervical spine surgery and posterior lumbar interbody fusion

主要目的：？评估重组巴曲酶与安慰剂对比在颈椎后路手术与腰椎后路椎间融合术受试者止血治疗的疗效；次要目的：评估重组巴曲酶与安慰剂对比在颈椎后路手术与腰椎后路椎间融合术受试者止血治疗的疗效、安全性以及免疫原性。

[Translation]

Primary purpose: ? To evaluate the efficacy of recombinant batroxobin compared with placebo in hemostatic treatment of subjects undergoing posterior cervical spine surgery and posterior lumbar interbody fusion; Secondary purpose: To evaluate the efficacy, safety and immunogenicity of recombinant batroxobin compared with placebo in hemostatic treatment of subjects undergoing posterior cervical spine surgery and posterior lumbar interbody fusion.

Start Date07 Apr 2021

Sponsor / Collaborator

Shanghai Wanxing Bio-pharmaceuticals Co., Ltd.

[+1]

CTR20181444 / CompletedPhase 1

重组巴曲酶在中国健康受试者中单次给药及多次给药的药代动力学特性、安全性和免疫原性的临床研究

[Translation] Clinical study on the pharmacokinetic properties, safety and immunogenicity of recombinant batroxobin after single and repeated administration in healthy Chinese subjects

主要目的：评估重组巴曲酶在单次、多次给药及剂量递增下在中国健康成年男性和女性受试者中的安全性。次要目的：评估重组巴曲酶在单次、多次给药及剂量递增下在中国健康成年男性和女性受试者中的药代动力学特性和免疫原性。

[Translation]

Primary objective: To evaluate the safety of recombinant batroxobin in Chinese healthy adult male and female subjects after single, multiple and dose escalation. Secondary objective: To evaluate the pharmacokinetic properties and immunogenicity of recombinant batroxobin in Chinese healthy adult male and female subjects after single, multiple and dose escalation.

Start Date19 Nov 2018

Sponsor / Collaborator

Shanghai Wanxing Bio-pharmaceuticals Co., Ltd.

[+1]

100 Clinical Results associated with Recombinant batroxobin(Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.)

100 Translational Medicine associated with Recombinant batroxobin(Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.)

100 Patents (Medical) associated with Recombinant batroxobin(Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.)

100 Deals associated with Recombinant batroxobin(Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB09005

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	CN	Shanghai Tenry Pharmaceutical Co. Ltd.	07 Apr 2021
Hemorrhage	Phase 3	CN	Shanghai Wanxing Bio-pharmaceuticals Co., Ltd.	07 Apr 2021
Hemorrhagic Disorders	Phase 2	CN	-	20 Nov 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2020	Not Applicable	-	-	Recombinant batroxobin	wpveurtfek(tbkhwcpllq) = uuxgvfbnzf svrsygimpp (bgmclkpftt ) View more	-	12 Jul 2020
				HemosIL fibrinogen-C	litdeqhxyc(sxpkhdeuua) = aycojqvizd tnyworkqbc (qxhpgpbjfh )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis