FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W3095306741> ?p ?o ?g. }

• W3095306741 endingPage "21" @default.
• W3095306741 startingPage "20" @default.
• W3095306741 abstract "There is a need for safe and effective reversal agents for patients on chronic anticoagulant therapy in cases such as serious or life-threatening bleeding, urgent or emergency surgery, after major trauma, or in cases of anticoagulant overdose. Ciraparantag, an anticoagulant reversal agent in clinical development, which is believed to bind directly to anticoagulant molecules through non-covalent bonds, with no binding to blood coagulation factors or proteins in the blood. Phase 2 clinical studies have shown that ciraparantag reverses anticoagulation in healthy volunteers treated with edoxaban, enoxaparin, apixaban, or rivaroxaban as assessed by manual whole blood clotting time (WBCT). WBCT is the key pharmacodynamic marker because ciraparantag is cationic and binds to the anionic substances in standard blood collection tubes, and to anionic, colloidal activators used in the traditional coagulation assays such as PT or aPTT. Therefore, such assays are not appropriate markers for measuring ciraparantag's effect. WBCT is a direct measure of the time required for blood clot formation ex vivo and uses blood drawn into reagent-free collection equipment, using only glass as the activating agent. A Phase 2b clinical study is planned to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation as measured by WBCT using an automated point-of-care (PoC) coagulometer (developed by Perosphere Technologies, Inc.) compared with a manual testing method. This is a randomized, double-blind, placebo-controlled study in healthy adults 18 to 75 years of age who are anticoagulated with apixaban (10 mg PO twice daily) or rivaroxaban (20 mg PO once daily). Subjects who reach steady-state anticoagulation will be stratified into 2 age groups and randomized 2:1 to receive a single IV dose of ciraparantag or placebo, followed by serial WBCT testing and standard safety assessments over 24 hours. The primary efficacy endpoint is based on the extent and timing of reversal of anticoagulation following ciraparantag administration as compared with placebo, based on WBCT measured using the PoC coagulometer. Manual WBCT testing also will be performed at selected timepoints in order to describe the correlation between results obtained with the two methods. The coagulometer is expected to provide greater sensitivity and precision compared to the manual method. Further details of the design of this study will be provided. The results of this study will inform dose selection for the future Phase 3 clinical trial and will provide data on the use of the PoC coagulometer for assessment of ciraparantag for reversal of anticoagulation. Disclosures Villano: Amag Pharmaceuticals, Inc.: Consultancy. Bakhru:Pherosphere Technologies, Inc.: Current Employment. Luo:Amag Pharmaceuticals, Inc.: Current Employment. Freedman:Amag Pharmaceuticals, Inc.: Current Employment. OffLabel Disclosure: Ciraparantag is an investigational drug being evaluated for the reversal of anticoagulation induced by direct oral anticoagulant (DOAC) therapies." @default.
• W3095306741 created "2020-11-09" @default.
• W3095306741 creator A5019504361 @default.
• W3095306741 creator A5019754066 @default.
• W3095306741 creator A5027463460 @default.
• W3095306741 creator A5088776058 @default.
• W3095306741 date "2020-11-05" @default.
• W3095306741 modified "2023-10-01" @default.
• W3095306741 title "Design of a Randomized, Controlled Study to Evaluate Reversal of Anticoagulation of Ciraparantag in Healthy Adults: Whole Blood Clotting Time Assessed By Automated and Manual Methods" @default.
• W3095306741 doi "https://doi.org/10.1182/blood-2020-142798" @default.
• W3095306741 hasPublicationYear "2020" @default.
• W3095306741 type Work @default.
• W3095306741 sameAs 3095306741 @default.
• W3095306741 citedByCount "0" @default.
• W3095306741 crossrefType "journal-article" @default.
• W3095306741 hasAuthorship W3095306741A5019504361 @default.
• W3095306741 hasAuthorship W3095306741A5019754066 @default.
• W3095306741 hasAuthorship W3095306741A5027463460 @default.
• W3095306741 hasAuthorship W3095306741A5088776058 @default.
• W3095306741 hasBestOaLocation W30953067411 @default.
• W3095306741 hasConcept C111113717 @default.
• W3095306741 hasConcept C112705442 @default.
• W3095306741 hasConcept C126322002 @default.
• W3095306741 hasConcept C141071460 @default.
• W3095306741 hasConcept C16124881 @default.
• W3095306741 hasConcept C1621761 @default.
• W3095306741 hasConcept C2776301958 @default.
• W3095306741 hasConcept C2777987278 @default.
• W3095306741 hasConcept C2778205648 @default.
• W3095306741 hasConcept C2778382381 @default.
• W3095306741 hasConcept C2778589496 @default.
• W3095306741 hasConcept C2778661090 @default.
• W3095306741 hasConcept C2779161974 @default.
• W3095306741 hasConcept C2780638905 @default.
• W3095306741 hasConcept C42219234 @default.
• W3095306741 hasConcept C71924100 @default.
• W3095306741 hasConcept C77171857 @default.
• W3095306741 hasConcept C98274493 @default.
• W3095306741 hasConceptScore W3095306741C111113717 @default.
• W3095306741 hasConceptScore W3095306741C112705442 @default.
• W3095306741 hasConceptScore W3095306741C126322002 @default.
• W3095306741 hasConceptScore W3095306741C141071460 @default.
• W3095306741 hasConceptScore W3095306741C16124881 @default.
• W3095306741 hasConceptScore W3095306741C1621761 @default.
• W3095306741 hasConceptScore W3095306741C2776301958 @default.
• W3095306741 hasConceptScore W3095306741C2777987278 @default.
• W3095306741 hasConceptScore W3095306741C2778205648 @default.
• W3095306741 hasConceptScore W3095306741C2778382381 @default.
• W3095306741 hasConceptScore W3095306741C2778589496 @default.
• W3095306741 hasConceptScore W3095306741C2778661090 @default.
• W3095306741 hasConceptScore W3095306741C2779161974 @default.
• W3095306741 hasConceptScore W3095306741C2780638905 @default.
• W3095306741 hasConceptScore W3095306741C42219234 @default.
• W3095306741 hasConceptScore W3095306741C71924100 @default.
• W3095306741 hasConceptScore W3095306741C77171857 @default.
• W3095306741 hasConceptScore W3095306741C98274493 @default.
• W3095306741 hasIssue "Supplement 1" @default.
• W3095306741 hasLocation W30953067411 @default.
• W3095306741 hasOpenAccess W3095306741 @default.
• W3095306741 hasPrimaryLocation W30953067411 @default.
• W3095306741 hasRelatedWork W2055495475 @default.
• W3095306741 hasRelatedWork W2083147923 @default.
• W3095306741 hasRelatedWork W2125101960 @default.
• W3095306741 hasRelatedWork W2151168214 @default.
• W3095306741 hasRelatedWork W2559597179 @default.
• W3095306741 hasRelatedWork W2897624230 @default.
• W3095306741 hasRelatedWork W2907999457 @default.
• W3095306741 hasRelatedWork W2980311801 @default.
• W3095306741 hasRelatedWork W3095306741 @default.
• W3095306741 hasRelatedWork W3096534353 @default.
• W3095306741 hasVolume "136" @default.
• W3095306741 isParatext "false" @default.
• W3095306741 isRetracted "false" @default.
• W3095306741 magId "3095306741" @default.
• W3095306741 workType "article" @default.