US2024009279A1PendingUtilityA1

Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf

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Assignee: TAKEDA PHARMACEUTICALS COPriority: Jul 7, 2017Filed: May 12, 2023Published: Jan 11, 2024
Est. expiryJul 7, 2037(~11 yrs left)· nominal 20-yr term from priority
Inventors:Miranda ChapmanBruce EwensteinBettina Ploder
A61K 38/36A61P 7/04
73
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Claims

Abstract

The present invention relates to method for pretreating a subject with severe von Willebrand disease prior to a surgical procedure comprising administering to the subject a dose ranging from about 20 IU/kg to about 60 IU/kg rVWF between about 12 hours and about 24 hours prior to the surgical procedure, and wherein Factor VIII is not administered with the rVWF prior to the surgical procedure.

Claims

exact text as granted — not AI-modified
1 . A method for pre-treatment of a subject with severe von Willebrand disease (VWD) prior to surgery, wherein said pre-treatment comprises administering 40-60 IU/kg of recombinant Von Willebrand Factor (rVWF) to said subject between 12 hours and 24 hours prior to the surgical procedure and wherein Factor VIII (FVIII) is not administered with the VWF prior to the surgical procedure, wherein the rVWF comprises highly multimeric VWF comprising at least 10 subunits. 
     
     
         2 . The method of  claim 1 , wherein said pre-treatment further comprises administering 5-90 IU/kg rVWF to said subject 1 hour prior to said surgical procedure. 
     
     
         3 . The method of  claim 1 , wherein FVIII is not administered after said surgical procedure. 
     
     
         4 . The method of  claim 1 , wherein said surgical procedure is selected from the group consisting of major surgery, minor surgery, and oral surgery. 
     
     
         5 . The method of  claim 1 , wherein said subject is administered 50-60 IU/kg rVWF between 12 hours and 24 hours prior to said surgical procedure and said surgical procedure is a minor surgical procedure. 
     
     
         6 . The method of  claim 1 , wherein said subject is administered 40-60 IU/kg rVWF between 12 hours and 24 hours prior to said surgical procedure and said surgical procedure is a major surgical procedure. 
     
     
         7 . The method of  claim 1 , wherein said subject is administered about 40 IU/kg rVWF between 12 hours and 24 hours prior to said surgical procedure and said surgical procedure is an oral surgical procedure. 
     
     
         8 . The method of  claim 1 , wherein said subject is administered 5-50 IU/kg rVWF 1 hour prior to the surgical procedure and said surgical procedure is a minor surgical procedure. 
     
     
         9 . The method of  claim 1 , wherein said subject is administered 15-90 IU/kg rVWF 1 hour prior to said surgical procedure and said surgical procedure is a major surgical procedure. 
     
     
         10 . The method of  claim 1 , wherein said subject is administered 20-50 IU/kg rVWF 1 hour prior to said surgical procedure and said surgical procedure is an oral surgical procedure. 
     
     
         11 . The method of  claim 1 , wherein said subject is administered 10-50 IU/kg rVWF during said surgical procedure and said surgical procedure is an oral surgical procedure. 
     
     
         12 . The method of  claim 1 , wherein said subject is administered 70-220 IU/kg rVWF after said surgical procedure. 
     
     
         13 . The method of  claim 1 , wherein said subject is administered 70-150 IU/kg rVWF after said surgical procedure and said surgical procedure is a minor surgical procedure. 
     
     
         14 . The method of  claim 1 , wherein said subject is administered 150-220 IU/kg rVWF after said surgical procedure and said surgical procedure is a major surgical procedure. 
     
     
         15 . The method of  claim 1 , wherein said subject is administered 20-50 IU/kg rVWF after said surgical procedure and said surgical procedure is an oral surgical procedure. 
     
     
         16 . The method of  claim 1 , wherein said subject is administered a total dosage of 100-220 IU/kg rVWF and said surgical procedure is a minor surgical procedure. 
     
     
         17 . The method of  claim 1 , wherein said subject is administered a total dosage of 220-320 IU/kg rVWF and said surgical procedure is a major surgical procedure. 
     
     
         18 . The method of  claim 1 , wherein said subject is administered a total dosage of IU/kg rVWF and said surgical procedure is an oral surgical procedure. 
     
     
         19 . The method of  claim 1 , wherein said surgical procedure is a major surgical procedure and said pre-treatment comprises administering at least two approximately equal doses of rVWF prior to the surgical procedure. 
     
     
         20 . The method of  claim 1 , wherein said surgical procedure is a minor surgical procedure and said pre-treatment comprises administering at least two doses of rVWF prior to the surgical procedure, wherein the first dose is larger than the second dose. 
     
     
         21 . The method of  claim 1 , wherein said surgical procedure is an oral surgical procedure and said pre-treatment comprises administering at least two approximately equal doses of rVWF prior to the surgical procedure. 
     
     
         22 . The method of  claim 1 , wherein the rVWF comprises highly multimeric VWF comprising over 40 subunits. 
     
     
         23 . The method of  claim 1 , wherein the rVWF comprises ultra-large multimers (ULMs), wherein the ULMs are at least 10,000 kDa. 
     
     
         24 . The method of  claim 1 , wherein the rVWF comprises a percentage of high molecular weight (BMW) rVWF multimers, wherein the BMW rVWF multimers comprises at least 10% rVWF decamers or higher order multimers.

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