DK2771003T3 - Galdesyrerecirkulationsinhibitorer til behandling af pædiatriske cholestatiske leversygdomme - Google Patents
Galdesyrerecirkulationsinhibitorer til behandling af pædiatriske cholestatiske leversygdomme Download PDFInfo
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- DK2771003T3 DK2771003T3 DK12801442.0T DK12801442T DK2771003T3 DK 2771003 T3 DK2771003 T3 DK 2771003T3 DK 12801442 T DK12801442 T DK 12801442T DK 2771003 T3 DK2771003 T3 DK 2771003T3
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- Prior art keywords
- asbti
- pediatric
- bile
- composition
- bile acid
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Claims (17)
1. Sammensætning omfattende en apikal natrium-afhængig galdesyretransporterinhibitor (ASBTI) der er
eller et farmaceutisk acceptabelt salt deraf til anvendelse i behandling af en pædiatrisk cholestatisk leversygdom hos en human pædiatrisk patient som er mellem 0 og 18 år.
2. Sammensætning til anvendelse ifølge krav 1 der behandler pruritus hos patienten.
3. Sammensætning til anvendelse ifølge krav 1 der behandler pædiatrisk hypercholemi hos patienten.
4. Sammensætning til anvendelse ifølge krav 1 der reducerer niveauet af serumgaldesyrer eller levergaldesyrer hos patienten.
5. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-4, hvor sammensætningen reducerer mindst 20% af serumgaldesyre- eller levergaldesyreniveauerne hos patienten.
6. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-5, hvor sammensætningen reducerer xanthoma, serumlipoprotein X, leverenzymer, bilirubin, intraenterocytgaldesyrer/-salte, eller nekrose og/eller beskadigelse af hepatocellulær struktur.
7. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-6, hvor sammensætningen er en dosisform der egner sig til behandling af en human pædiatrisk patient.
8. Sammensætning til anvendelse ifølge krav 7, hvor dosisformen er valgt fra en opløsning, sirup, suspension, eliksir, pulver til mikstur som suspension eller opløsning, dispergerbar/brusetablet, tyggetablet, tyggegummi, slikkepind, freezer pops, pastiller, orale tynde strimler, oralt opløselig tablet, lille pose, blød gelatinekapsel, og oralt strøpulver eller granulater.
9. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-8, hvor dosen af ASBTI'en er mellem 10 pg/kg/dag og 300 pg/kg/dag.
10. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-8, hvor dosen af ASBTI'en er en hvilken som helst dosis fra 14pg/kg/dag til 280 pg/kg/dag.
11. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-8, hvor dosen af ASBTI'en er en hvilken som helst dosis fra 14pg/kg/dag til 140 pg/kg/dag.
12. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-8, hvor dosen omfatter mellem 0,1 til 20 mg ASBTI.
13. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-12, hvor den pædiatriske cholestatiske leversygdom er progressiv familiær intrahepatisk cholestase (PFIC), PFIC type 1, PFIC type 2, PFIC type 3, Alagilles syndrom, Dubin-Johnson syndrom, galdeatresi, post-Kasai-galdeatresi, post-levertransplantationsgaldeatresi, post-levertransplantationscholestase, post-levertransplantations-associeret leversygdom, tarmsvigts-associeret leversygdom, galdesyre-medieret leverbeskadigelse, pædiatrisk primær skleroserende cholangit, MRP2-mangelsyndrom, neonatal skleroserende cholangit, en pædiatrisk obstruktiv cholestase, en pædiatrisk ikke-obstruktiv cholestase, en pædiatrisk extrahepatisk cholestase, en pædiatrisk intrahepatisk cholestase, en pædiatrisk primær intrahepatisk cholestase, en pædiatrisk sekundær intrahepatisk cholestase, godartet tilbagevendende intrahepatisk cholestase (BRIC), BRIC type 1, BRIC type 2, BRIC type 3, total parenteral ernærings-associeret cholestase, paraneoplastisk cholestase, Stauffer-syndrom, lægemiddel-associeret cholestase, infektions associeret cholestase eller galdestenssygdom.
14. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-13, hvor den pædiatriske cholestatiske leversygdom er kendetegnet ved et eller flere symptomer valgt fra gulsot, pruritus, cirrose, hypercholemi, neonatal respiratorisk distress-syndrom, lungepneumoni, øget serumkoncentration af galdesyrer, øget leverkoncentration af galdesyrer, øget serumkoncentration af bilirubin, hepatocellulær læsion, ardannelse på leveren, leversvigt, hepatomegali, xanthoma, malabsorption, splenomegali, diarré, pancreatitis, hepatocellulær nekrose, dannelse af kæmpe celler, hepatocellulært carcinom, blødning i mavetarmsystemet, portal hypertension, høretab, træthed, appetittab, anoreksi, besynderlig lugt, mørk urin, let afføring, steatorrhea, trivselsforstyrrelse og nyresvigt.
15. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-14, hvor den humane pædiatriske patient er mellem 6 måneder og 12 år gammel.
16. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-15, hvor mindre end 10% af ASBTI'en absorberes systematisk.
17. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-16, hvor sammensætningen endvidere omfatter et galdesyresekvestreringsmiddel eller bindemiddel.
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PCT/US2012/062284 WO2013063512A1 (en) | 2011-10-28 | 2012-10-26 | Bile acid recycling inhibitors for treatment of pediatric cholestatic liver diseases |
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