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ALIVER SIGNED

Development of DIALIVE, a novel Liver Dialysis Device for the treatment of patients with Acute on Chronic Liver Failure (ACLF)

Total Cost €

0

EC-Contrib. €

0

Partnership

0

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 ALIVER project word cloud

Explore the words cloud of the ALIVER project. It provides you a very rough idea of what is the project "ALIVER" about.

safety    incidence    trl7    dialive    perform    industry    successful    immune    licensee    function    incorporates    health    18    proteins    patients    protein    contributes    exploited    models    economic    protected    circulating    grifols    world    organs    comprised    prolonged    discovery    irreversibly    disseminated    ethics    clinically    chronic    plan    clinical    unmet    period    grant    progress    efficacious    death    infection    detoxification    accumulation    patents    charities    bound    treatment    170k    trials    prolong    acute    aliver    reimbursement    multiorgan    dialysis    proposes    transplantation    grow    healthcare    benefits    safe    trl5    smes    shown    life    albumin    limited    mark    ce    replacement    liver    approval    endotoxemia    aclf    efficacy    disease    toxins    hospitals    strategy    regulatory    risk    jobs    susceptibility    bodies    create    plasma    animal    endotoxin    experts    removal    consultation    positive    confirms    benefit    survival    die    company    device   

Project "ALIVER" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITY COLLEGE LONDON 

Organization address
address: GOWER STREET
city: LONDON
postcode: WC1E 6BT
website: n.a.

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country United Kingdom [UK]
 Project website http://www.aliver.info
 Total cost 7˙846˙088 €
 EC max contribution 6˙478˙737 € (83%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2020-09-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
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

Map

 Project objective

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.

 Deliverables

List of deliverables.
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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