Claims for Patent: 10,215,746

Summary for Patent: 10,215,746

Title:	Methods for diagnosis and intervention of hepatic disorders
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.
Inventor(s):	Everson; Gregory Thomas (Englewood, CO)
Assignee:	The Regents of the University of Colorado, a body corporate (Denver, CO)
Application Number:	15/195,762
Patent Claims:	1. 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 intravenous dose of a first distinguishable cholate compound in aqueous sodium bicarbonate solution; a second component comprising one or more vials, each vial comprising a single oral dose of a second distinguishable cholate compound; a third component comprising a plurality of sample collection tubes and/or transport vials; a fourth component comprising a suitable container means; and a fifth component comprising one or more vials, each vial comprising a quantity of human albumin for mixing with the single intravenous dose of the first distinguishable cholate compound prior to intravenous administration. 2. The kit according to claim 1, wherein the human albumin is human serum albumin. 3. The kit according to claim 1, wherein the first and second distinguishable cholate compounds are stable isotope labeled distinguishable cholate compounds. 4. The kit according to claim 1, wherein the first and second distinguishable cholate compounds are stable isotope labeled distinguishable cholate compounds independently selected from the group consisting of stable isotope labeled distinguishable cholic acids, stable isotope labeled distinguishable glycine-conjugated cholic acids, stable isotope labeled distinguishable taurine-conjugated cholic acids, stable isotope labeled distinguishable chenodeoxycholic acids, stable isotope labeled distinguishable glycine-conjugated chenodeoxycholic acids, and stable isotope labeled distinguishable taurine-conjugated chenodeoxycholic acids. 5. The kit according to claim 4, wherein the first and second distinguishable cholate compounds are stable isotope labeled distinguishable cholic acids. 6. The kit according to claim 5, wherein the first and second stable isotope labeled distinguishable cholic acids are independently labeled with one or more of the group consisting of .sup.2H, .sup.13C, .sup.15N, and .sup.18O stable isotopes. 7. The kit according to claim 6, wherein the first and second stable isotope labeled distinguishable cholic acids are different. 8. The kit according to claim 7, wherein the first and second stable isotope labeled distinguishable cholic acids are selected from the group consisting of 2,2,4,4-.sup.2H-cholic acid and 24-.sup.13C cholic acid. 9. The kit according to claim 8, wherein the first stable isotope labeled distinguishable cholic acid is 24-.sup.13C cholic acid and the second stable isotope labeled distinguishable cholic acid is 2,2,4,4-.sup.2H cholic acid. 10. The kit according to claim 9, wherein the single oral dose of the second stable isotope labeled distinguishable cholic acid is in a form selected from the group consisting of a powder form and a solution form. 11. The kit according to claim 10, wherein the single oral dose of stable isotope labeled second distinguishable cholic acid comprises 2,2,4,4-.sup.2H-cholic acid in aqueous sodium bicarbonate solution. 12. The kit according to claim 10, wherein the single intravenous dose of the first distinguishable cholic acid comprises 24-.sup.13C-cholic acid. 13. The kit according to claim 1, wherein the container means is selected from one or more of the group consisting of plastic containers, reagent containers, vials, tubes, flasks, and bottles. 14. The kit according to claim 1, wherein the kit further comprises one or more of the group consisting of shipping box, labels, instructions, package inserts, diluent, flavorings, syringes, indwelling catheter, 3-way stopcock, timer, and transfer pipets. 15. The kit according to claim 14, wherein the diluent is selected from the group consisting of water, sodium bicarbonate solution, non-citrus juice, and normal saline (NS). 16. The kit according to claim 14, wherein the shipping box comprises a single box for both shipping the vials to a health care practitioner and shipping the samples from the health care practitioner to a reference lab for analysis. 17. The kit according to claim 1, wherein the sample collection tubes comprise one or more sets of sterile blood-serum sample collection tubes, wherein each set consists of enough tubes for collection of a plurality of samples from the subject over a period of no more than 180 minutes after administration of the first and second distinguishable cholate compounds. 18. The kit of claim 17, wherein each set of the one or more sets of sterile blood-serum sample collection tubes consists of enough tubes for collecting blood or serum samples from the subject over intervals of two to seven time points spanning time periods of 5 to no more than 180 minutes. 19. The kit of claim 18, wherein each set of the one or more sets of sterile blood-serum sample collection tubes consists of enough tubes for collection of 5 samples from the subject over a period of 90 minutes after administration of the distinguishable cholate compounds. 20. The kit of claim 18, wherein each set of the one or more sets of sterile blood-serum sample collection tubes consists of 5 or 6 sample collection tubes.

Details for Patent 10,215,746

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2025-01-26
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2025-01-26
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2025-01-26
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2025-01-26
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2025-01-26
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2025-01-26
Csl Behring Llc	ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5	albumin (human)	Injection	103955	03/17/2000		2025-01-26