Methods for Diagnosis and Intervention of Hepatic Disorders
First Claim
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1. A method for assessment of hepatic function in a subject, the method comprising:
- administering orally an isotopically labeled cholic acid to a subject with, or suspected of having or developing, a hepatic disorder, wherein no additional cholic acid compound is intravenously co-administered;
collecting samples from the subject over intervals for a period of less than 3 hours after administration of the agents to the subject; and
measuring the clearance of the orally administered isotopically labeled cholic acid as an indicator of hepatic function in the subject.
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Abstract
The disclosure provides a method for quantification of hepatic function in a subject comprising measuring the clearance of an orally administered isotopically labeled cholic acid in a subject with, or suspected of having or developing, a hepatic disorder, for example, chronic hepatitis C. The disclosure further provides methods and kits for assessment of hepatic function.
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Citations
37 Claims
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1. A method for assessment of hepatic function in a subject, the method comprising:
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administering orally an isotopically labeled cholic acid to a subject with, or suspected of having or developing, a hepatic disorder, wherein no additional cholic acid compound is intravenously co-administered; collecting samples from the subject over intervals for a period of less than 3 hours after administration of the agents to the subject; and measuring the clearance of the orally administered isotopically labeled cholic acid as an indicator of hepatic function in the subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. A method for assessment of the progression of at least one hepatic condition in a subject, the method comprising:
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administering orally a first distinguishable isotopically labeled cholic acid to a subject having, or suspected of having or developing, a hepatic disorder; co-administering intravenously a second distinguishable isotopically labeled cholic acid to the subject; collecting blood or serum samples over intervals for a period of less than 3 hours after administration of the agents to the subject; quantifying the first and the second isotopically labeled cholic acids in the samples by HPLC-MS; and calculating the cholate shunt using the formula;
AUCoral/AUCiv×
Doseiv/Doseoral×
100%;wherein AUCoral is the area under the curve of the serum concentrations of the first cholic acid and AUCiv is the area under the curve of the second cholic acid; and
wherein the cholate shunt is an indicator of the progression of at least one hepatic disorder of the subject. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
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31. A kit of components for determining one or both of cholate clearance and cholate shunt in a subject with, or suspected of having or developing, a hepatic disorder;
- the kit comprising
a first component comprising one or more vials, each vial comprising a single oral dose of a first distinguishable cholate compound; and a second component comprising one or more vials, each vial comprising a single intravenous dose of a second distinguishable cholate compound. - View Dependent Claims (32, 33, 34, 35, 36, 37)
- the kit comprising
Specification