(A19_067_2015_0670020_1309) DEVELOPMENT OF METHODS FOR THE PURIFICATION OF PLASMA FACTOR V, FOR THE PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES FOR DEFICIENT PERSONS. (Q2167495)
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Project Q2167495 in Italy
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | (A19_067_2015_0670020_1309) DEVELOPMENT OF METHODS FOR THE PURIFICATION OF PLASMA FACTOR V, FOR THE PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES FOR DEFICIENT PERSONS. |
Project Q2167495 in Italy |
Statements
65,296.5 Euro
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130,593.0 Euro
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50.0 percent
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20 November 2015
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13 April 2021
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13 April 2021
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UNITECH S.R.L.
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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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LE PROJET VISE À DÉVELOPPER, EN TANT QUE MÉDICAMENT ORPHELIN, UN CONCENTRÉ DE PV PLASMATIQUE HUMAIN QUI PRÉVIENT ET TRAITE LE SAIGNEMENT DES SUJETS DÉFICIENTS. PAS À L’HEURE ACTUELLE? AUCUN CONCENTRÉ DE PV DISPONIBLE SUR LE MARCHÉ ET LES ÉPISODES DE SAIGNEMENT AIGU DES PATIENTS ATTEINTS DE CE FACTEUR SONT TRAITÉS AVEC DU PLASMA FRAIS CONGELÉ AFIN DE MAINTENIR DES TAUX SANGUINS DE PV SUPÉRIEURS À 20 %; À CETTE FIN SOUVENT? PERFUSION REQUISE DE 750-1000 ML DE LIQUIDES AYANT DES EFFETS SECONDAIRES POSSIBLES TELS QUE: SURCHARGE VOLUMIQUE, RÉACTIONS ALLERGIQUES ET DÉVELOPPEMENT D’ALANTIBODIES. LE MANQUE D’INTÉRÊT COMMERCIAL POUR UN PRODUIT À BASE DE PV TIENT AU FAIT QU’UNE TELLE MALADIE? EXTRÊMEMENT RARE (PRÉVALENCE DE 1:1 000 000) ET CONNAISSANCE PEU CLAIRE DES MANIFESTATIONS CLINIQUES EN RAISON DU FAIBLE NOMBRE DE SUJETS IMPLIQUÉS. UN CONCENTRÉ DE PV POURRAIT ÉGALEMENT ÊTRE UTILISÉ POUR UNE AUTRE MALADIE RARE TELLE QUE LA PÉNURIE COMBINÉE DE PV ET DE FVIII, AVEC UNE PRÉVALENCE SIMILAIRE ET (French)
23 December 2021
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Identifiers
D56G15001290009
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