Explore the words cloud of the ALIVER project. It provides you a very rough idea of what is the project "ALIVER" about.
The following table provides information about the project.
UNIVERSITY COLLEGE LONDON
|Coordinator Country||United Kingdom [UK]|
|Total cost||7˙846˙088 €|
|EC max contribution||6˙478˙737 € (83%)|
1. H2020-EU.3.1.3. (Treating and managing disease)
|Duration (year-month-day)||from 2017-01-01 to 2020-09-30|
Take a look of project's partnership.
|1||UNIVERSITY COLLEGE LONDON||UK (LONDON)||coordinator||941˙912.00|
|2||YAQRIT LIMITED||UK (LONDON)||participant||2˙821˙450.00|
|3||FAKKEL BVBA||BE (LANDEN)||participant||1˙263˙250.00|
|4||ROYAL FREE LONDON NHS FOUNDATION TRUST||UK (LONDON)||participant||433˙750.00|
|5||IBM IRELAND LIMITED||IE (Ballsbridge)||participant||261˙250.00|
|6||ALBUTEC GMBH||DE (ROSTOCK)||participant||204˙500.00|
|7||ASSISTANCE PUBLIQUE HOPITAUX DE PARIS||FR (PARIS)||participant||176˙000.00|
|8||UNIVERSITATSMEDIZIN ROSTOCK||DE (ROSTOCK)||participant||140˙125.00|
|9||EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF)||ES (BARCELONA)||participant||120˙500.00|
|10||SERVICIO MADRILENO DE SALUD||ES (MADRID)||participant||116˙000.00|
|11||EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER||CH (ZURICH)||participant||0.00|
Liver disease incidence is increasing and about 170K patients die from liver failure each year in Europe. In liver failure, the accumulation of protein bound toxins and increased susceptibility to infection cause multiorgan failure and death. Liver transplantation is the only treatment known to prolong the life but is limited by availability of organs. A clinically efficacious ‘liver dialysis device’ is an unmet clinical need. The ALIVER Consortium has developed and optimised a novel ‘liver dialysis device’, DIALIVE. The DIALIVE device is protected by world-wide patents and is based upon our discovery that (i) albumin, a circulating protein involved in detoxification is reduced irreversibly in function and (ii) endotoxemia contributes to increased risk of infection in liver failure. DIALIVE incorporates albumin removal and replacement and, endotoxin removal and is a TRL5. In animal models of liver failure, DIALIVE was shown to be easy to use, safe, reduced endotoxemia and, improved albumin and immune function and, prolonged survival. The ALIVER Consortium, which is comprised of experts in liver failure, SMEs and charities proposes to perform clinical trials of DIALIVE in patients with acute on chronic liver failure (ACLF). During the grant period a CE-mark will be obtained and the device will progress to a TRL7/8. Consultation with Regulatory bodies confirms that if the trials are successful, a CE-mark is highly likely. Grifols, a large plasma proteins company is a potential licensee of the technology if the studies proposed by the ALIVER Consortium are positive. We plan to take the project through regulatory and ethics approval and perform two studies to define its safety and efficacy in ACLF patients in 18 European hospitals; define health economic benefits to the EU and define a reimbursement strategy. The results will be disseminated widely and results exploited to benefit patients, EU healthcare system, create new jobs and grow healthcare Industry in Europe.
|CE-mark for DIALIVE||Documents, reports||2020-02-20 09:41:22|
|Report of statistical visualizations from ALIVER datamart.||Documents, reports||2020-02-20 09:41:22|
|Statistical models using the data generated in the ALIVER trials.||Documents, reports||2020-02-20 09:41:22|
|project web site||Documents, reports||2020-02-20 09:41:22|
|Generation of Standard operating procedures and trouble shooting manual for DIALIVE||Documents, reports||2020-02-20 09:41:22|
|\'First study subject approvals package\' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trial||Documents, reports||2020-02-20 09:41:22|
|Establish requirements of the datamart and data fusion||Documents, reports||2020-02-20 09:41:22|
|Setting up the eCRFs and the associated database for the proposed SAFETY and EFFICACY clinical trials||Documents, reports||2020-02-20 09:41:21|
|Technical file and Design Dossier||Documents, reports||2020-02-20 09:41:21|
|Supply and Train clinical teams at individual sites about the use of DIALIVE||Documents, reports||2020-02-20 09:41:22|
|Supply agreement for filters and purchase of Prismaflex for the different sites||Documents, reports||2020-02-20 09:41:22|
|\'All approvals package\' Contracts with relevant hospitals for the SAFETY clinical trial and for the EFFICACY trial||Documents, reports||2020-02-20 09:41:21|
|Packaging and labelling of the filters for delivery to clinical trial sites||Documents, reports||2020-02-20 09:41:22|
|Incorporation of the Albutec Hepalbinâ„¢ filter into DIALIVE||Documents, reports||2020-02-20 09:41:22|
|Regulatory approval received for pre-CE mark Safety clinical trial and EFFICACY trial||Documents, reports||2020-02-20 09:41:21|
|Documentation and implementation of QMS per ISO 13485||Documents, reports||2020-02-20 09:41:21|
|Datamart logical data Model (data fusion) analysis of available data||Documents, reports||2020-02-20 09:41:22|
|Clinical Trial Reports for the SAFETY and EFFICACY trial||Documents, reports||2020-02-20 09:41:22|
Take a look to the deliverables list in detail: detailed list of ALIVER deliverables.
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The information about "ALIVER" are provided by the European Opendata Portal: CORDIS opendata.
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