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Coagulant Effect and Tolerability of Yeast-Produced Recombinant Batroxobin in Healthy Adult Subjects

DC FieldValueLanguage
dc.contributor.author김춘옥-
dc.contributor.author박민수-
dc.contributor.author박민수-
dc.date.accessioned2019-03-15T02:29:21Z-
dc.date.available2019-03-15T02:29:21Z-
dc.date.issued2018-
dc.identifier.issn1173-2563-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/167515-
dc.description.abstractBACKGROUND AND OBJECTIVE: Batroxobin, a snake venom thrombin-like enzyme, converts fibrinogen into fibrin by cleaving fibrinopeptide A. It is used for hemostasis; however, the supply of native batroxobin is limited. Therefore, we developed a recombinant batroxobin (r-batroxobin) from Pichia pastoris and evaluated its pharmacodynamics and safety in humans. METHODS: A randomized, double-blind, placebo-controlled, single ascending-dose study was performed. Eight healthy subjects were enrolled in each r-batroxobin dose group (2.5, 5.0, or 10.0 BU/2.0 mL administered intravenously), and randomized to receive r-batroxobin (n = 6) or matching placebo (n = 2). Safety was evaluated during the study, and pharmacodynamics was assessed using prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin time (TT), and fibrinogen level. RESULTS: All subjects in each cohort completed the study. No significant changes in PT or aPTT occurred after intravenous r-batroxobin administration. Compared with the placebo group, the fibrinogen level in all r-batroxobin dose groups decreased significantly to 8.68-33.57% from the baseline within 12 h (p ≤ 0.05). The TT in the 5.0 and 10.0 BU/2.0 mL groups significantly increased to 7.53-18.48% from baseline within 12 h compared with that of the placebo group (p ≤ 0.05), whereas that of the 2.5 BU/2.0 mL group exhibited non-significant changes compared with the placebo group. No serious adverse events occurred. CONCLUSIONS: A single intravenous injection of r-batroxobin within a dose range of 2.5-10.0 BU/2.0 mL was well tolerated and resulted in a significant decrease in fibrinogen and prolongation of TT. REGISTRATION: This study is registered at the Clinical Research Information Service (CRIS, http://cris.nih.go.kr ), number KCT0002518.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherSpringer International-
dc.relation.isPartOfCLINICAL DRUG INVESTIGATION-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHBatroxobin/administration & dosage*-
dc.subject.MESHBatroxobin/blood*-
dc.subject.MESHBlood Coagulation/drug effects*-
dc.subject.MESHBlood Coagulation/physiology-
dc.subject.MESHCohort Studies-
dc.subject.MESHDose-Response Relationship, Drug-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHHealthy Volunteers-
dc.subject.MESHHemostatics/administration & dosage*-
dc.subject.MESHHemostatics/blood*-
dc.subject.MESHHumans-
dc.subject.MESHInjections, Intravenous-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHProthrombin Time*/methods-
dc.subject.MESHRecombinant Proteins/administration & dosage-
dc.subject.MESHThrombin/metabolism-
dc.subject.MESHYoung Adult-
dc.titleCoagulant Effect and Tolerability of Yeast-Produced Recombinant Batroxobin in Healthy Adult Subjects-
dc.typeArticle-
dc.contributor.collegeOthers-
dc.contributor.departmentSeverance Hospital (세브란스병원)/임상시험센터-
dc.contributor.googleauthorSeuk Keun Choi-
dc.contributor.googleauthorChan Wha Kim-
dc.contributor.googleauthorJong-Tak Kim-
dc.contributor.googleauthorYoung Seomun-
dc.contributor.googleauthorMin Soo Park-
dc.contributor.googleauthorChoon Ok Kim-
dc.identifier.doi10.1007/s40261-018-0673-x-
dc.contributor.localIdA04735-
dc.contributor.localIdA01468-
dc.contributor.localIdA01468-
dc.contributor.localIdA01468-
dc.contributor.localIdA01468-
dc.relation.journalcodeJ03594-
dc.identifier.eissn1179-1918-
dc.identifier.pmid29978322-
dc.identifier.urlhttps://link.springer.com/article/10.1007%2Fs40261-018-0673-x-
dc.contributor.alternativeNameKim, Choon Ok-
dc.contributor.affiliatedAuthor김춘옥-
dc.contributor.affiliatedAuthor박민수-
dc.contributor.affiliatedAuthor박민수-
dc.contributor.affiliatedAuthor박민수-
dc.contributor.affiliatedAuthor박민수-
dc.citation.volume38-
dc.citation.number9-
dc.citation.startPage829-
dc.citation.endPage835-
dc.identifier.bibliographicCitationCLINICAL DRUG INVESTIGATION , Vol.38(9) : 829-835, 2018-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers

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