US2023146264A1PendingUtilityA1

Treatment of Ascites

70
Assignee: BIOVIE INCPriority: Jun 30, 2015Filed: Jun 3, 2022Published: May 11, 2023
Est. expiryJun 30, 2035(~9 yrs left)· nominal 20-yr term from priority
A61P 25/00A61P 7/04A61P 1/00A61P 13/12A61P 9/00A61P 1/16A61P 29/00A61P 31/04A61P 7/10A61K 38/095
70
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Claims

Abstract

A method for treating ascites patients by administering the peptide drug terlipressin by continuous infusion. The patients include those whose ascites condition has not progressed to hepatorenal syndrome (HRS). Administration may be accomplished with a continuous infusion pump.

Claims

exact text as granted — not AI-modified
1 .- 20 . (canceled) 
     
     
         21 . A method for treating ascites in a non-hepatorenal syndrome (HRS) patient diagnosed with ascites due to liver cirrhosis, the method consisting of administering a continuous infusion of terlipressin or salt thereof to the patient at a continuous infusion dose of about 2.0 mg to about 12.0 mg of terlipressin per day for a duration of about one day to about twelve months, wherein the patient is not hospitalized and the patient is not administered diuretics during the duration, and wherein the ascites in the patient is reduced. 
     
     
         22 . The method of  claim 21 , wherein the continuous infusion of terlipressin is administered with an ambulatory infusion pump. 
     
     
         23 . The method of  claim 21 , wherein the administration is provided on an out-patient basis. 
     
     
         24 . The method of  claim 21 , wherein the continuous infusion dose escalates over the duration. 
     
     
         25 . The method of  claim 21 , wherein the continuous infusion dose is about 3 mg of terlipressin per day. 
     
     
         26 . The method of  claim 21 , wherein the patient is further diagnosed with hyponatremia. 
     
     
         27 . The method of  claim 21 , wherein reduced ascites in the patient is indicated by a reduction in the frequency of paracentesis procedures in a given time period after beginning the continuous infusion. 
     
     
         28 . The method of  claim 21 , wherein reduced ascites in the patient is indicated by a reduction in the volume of ascitic fluid that is removed per paracentesis procedure after beginning the continuous infusion 
     
     
         29 . The method of  claim 21 , wherein reduced ascites in the patient is indicated by an increase in urinary sodium excretion during treatment with terlipressin. 
     
     
         30 . The method in  claim 21 , wherein the reduced ascites in the patient is indicated by a reduction in patient weight during treatment with terlipressin.

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