Topical rhThrombin as an Adjunct to Hemostasis During Segmental

Status Completed

Clinical Trial Summary

rhThrombin is a serine protease from human.The study is to assess the Safety, Tolerability, Immunogenicity and efficacy of rhThrombin.

Clinical Trial Description

The study is a randomized, single-blind,blank controlled phase 1&2 trial ,including 3 independent parts toevaluate the safety,efficacy and immunogenicity. The first part is ascending dose,blank control tolerability and safety study. The Starting doses from 500IU/ml to 1000IU/mL and 2000IU/mL to evaluate the safety,efficacy. The second part is randomized, single-blind, blank controlled study to evaluate safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group which with absorbable collagen sponge when used. The third part is randomized, single-blind, blank controlled study to evaluate safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group which directly sprayed on hemorrhagic point when used. ;

Study Design

Related Conditions & MeSH terms

Hepatectomy

Clinical Trial Details

NCT number	NCT03611426
Study type	Interventional
Source	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	November 29, 2017
Completion date	July 30, 2019

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Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms