(A19_067_2015_0670020_1043) DEVELOPMENT OF METHODS FOR THE PURIFICATION OF PLASMA FACTOR V, FOR THE PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES FOR DEFICIENT PERSONS. (Q2167483): Difference between revisions
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Revision as of 06:40, 3 November 2020
Project Q2167483 in Italy
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | (A19_067_2015_0670020_1043) DEVELOPMENT OF METHODS FOR THE PURIFICATION OF PLASMA FACTOR V, FOR THE PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES FOR DEFICIENT PERSONS. |
Project Q2167483 in Italy |
Statements
261,959.98 Euro
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523,919.95 Euro
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50.0 percent
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1 April 2016
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13 April 2021
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13 April 2021
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KEDRION SPA
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43°46'11.53"N, 11°15'20.09"E
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IL PROGETTO SI PROPONE DI SVILUPPARE, COME FARMACO ORFANO, UN CONCENTRATO DI FV DA PLASMA UMANO IN GRADO DI PREVENIRE E TRATTARE LE EMORRAGIE DEI SOGGETTI CARENTI. ALLO STATO ATTUALE NON ? DISPONIBILE SUL MERCATO ALCUN CONCENTRATO A BASE DI FV E GLI EPISODI EMORRAGICI ACUTI DEI PAZIENTI CON DEFICIT DI TALE FATTORE VENGONO TRATTATI CON PLASMA FRESCO CONGELATO IN MODO DA MANTENERE I LIVELLI EMATICI DI FV SOPRA IL 20%; A TAL FINE SPESSO ? NECESSARIA L?INFUSIONE DI 750-1000 ML DI LIQUIDI CON POSSIBILI EFFETTI COLLATERALI QUALI: SOVRACCARICO DI VOLUME, REAZIONI ALLERGICHE E SVILUPPO DI ALLOANTICORPI. LO SCARSO INTERESSE COMMERCIALE PER UN PRODOTTO A BASE DI FV DERIVA DAL FATTO CHE TALE PATOLOGIA ? ESTREMAMENTE RARA (PREVALENZA DI 1:1.000.000) E LA CONOSCENZA DELLE MANIFESTAZIONI CLINICHE NON CHIARA A CAUSA DEL BASSO NUMERO DI SOGGETTI COINVOLTI. UN CONCENTRATO DI FV POTREBBE ESSERE UTILIZZATO ANCHE PER UN?ALTRA PATOLOGIA RARA QUALE LA CARENZA CONGIUNTA DI FV E FVIII, CON PREVALENZA SIMILE E (Italian)
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THE AIM OF THE PROJECT IS TO DEVELOP, AS AN ORPHAN DRUG, A HUMAN PLASMA CONCENTRATE THAT IS CAPABLE OF PREVENTING AND TREATING THE HAEMORRHAGES OF THE DEFICIENT PERSONS. TO THE CURRENT STATE? THERE IS NO PV BASED CONCENTRATE AVAILABLE ON THE MARKET AND THE ACUTE BLEEDING EPISODES OF PATIENTS WITH A DEFICIT IN THIS FACTOR ARE TREATED WITH FRESH FROZEN PLASMA SO AS TO KEEP PV BLOOD LEVELS ABOVE 20 %; TO THIS END OFTEN? 750 TO 1 000 ML OF LIQUIDS WITH POSSIBLE SIDE-EFFECTS SUCH AS: VOLUME OVERLOAD, ALLERGIC REACTIONS AND DEVELOPMENT OF ALLOANTICORPI. DOES LITTLE COMMERCIAL INTEREST IN A PV PRODUCT RESULT FROM THIS CONDITION? EXTREMELY RARE (PREVALENCE OF 1: 1.000.000) AND KNOWLEDGE OF CLINICAL MANIFESTATIONS THAT ARE UNCLEAR DUE TO THE LOW NUMBER OF ACTORS INVOLVED. A PV CONCENTRATE COULD ALSO BE USED FOR ANOTHER RARE DISEASE SUCH AS THE JOINT SHORTAGE OF PV AND FVIII, WITH A SIMILAR PREVALENCE AND (English)
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Identifiers
D56G15001290009
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