Cited 3 times in
Coagulant Effect and Tolerability of Yeast-Produced Recombinant Batroxobin in Healthy Adult Subjects
DC Field | Value | Language |
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dc.contributor.author | 김춘옥 | - |
dc.contributor.author | 박민수 | - |
dc.date.accessioned | 2019-03-15T02:29:21Z | - |
dc.date.available | 2019-03-15T02:29:21Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 1173-2563 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/167515 | - |
dc.description.abstract | BACKGROUND 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.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Springer International | - |
dc.relation.isPartOf | CLINICAL DRUG INVESTIGATION | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Batroxobin/administration & dosage* | - |
dc.subject.MESH | Batroxobin/blood* | - |
dc.subject.MESH | Blood Coagulation/drug effects* | - |
dc.subject.MESH | Blood Coagulation/physiology | - |
dc.subject.MESH | Cohort Studies | - |
dc.subject.MESH | Dose-Response Relationship, Drug | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Hemostatics/administration & dosage* | - |
dc.subject.MESH | Hemostatics/blood* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Injections, Intravenous | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Prothrombin Time*/methods | - |
dc.subject.MESH | Recombinant Proteins/administration & dosage | - |
dc.subject.MESH | Thrombin/metabolism | - |
dc.subject.MESH | Young Adult | - |
dc.title | Coagulant Effect and Tolerability of Yeast-Produced Recombinant Batroxobin in Healthy Adult Subjects | - |
dc.type | Article | - |
dc.contributor.college | Others | - |
dc.contributor.department | Severance Hospital (세브란스병원)/임상시험센터 | - |
dc.contributor.googleauthor | Seuk Keun Choi | - |
dc.contributor.googleauthor | Chan Wha Kim | - |
dc.contributor.googleauthor | Jong-Tak Kim | - |
dc.contributor.googleauthor | Young Seomun | - |
dc.contributor.googleauthor | Min Soo Park | - |
dc.contributor.googleauthor | Choon Ok Kim | - |
dc.identifier.doi | 10.1007/s40261-018-0673-x | - |
dc.contributor.localId | A04735 | - |
dc.contributor.localId | A01468 | - |
dc.relation.journalcode | J03594 | - |
dc.identifier.eissn | 1179-1918 | - |
dc.identifier.pmid | 29978322 | - |
dc.identifier.url | https://link.springer.com/article/10.1007%2Fs40261-018-0673-x | - |
dc.contributor.alternativeName | Kim, Choon Ok | - |
dc.contributor.affiliatedAuthor | 김춘옥 | - |
dc.contributor.affiliatedAuthor | 박민수 | - |
dc.citation.volume | 38 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 829 | - |
dc.citation.endPage | 835 | - |
dc.identifier.bibliographicCitation | CLINICAL DRUG INVESTIGATION , Vol.38(9) : 829-835, 2018 | - |
dc.identifier.rimsid | 45850 | - |
dc.type.rims | ART | - |
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