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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 €

EC-Contrib. €

Partnership

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Outcomes and
results

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 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.	UK (LONDON)	coordinator	941˙912.00
2	YAQRIT LIMITED YAQRIT LIMITED Organization address address: THE NETWORK BUILDING 97 TOTTENHAM COURT ROAD city: LONDON postcode: W1T 4TP 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.	UK (LONDON)	participant	2˙821˙450.00
3	FAKKEL BVBA FAKKEL BVBA Organization address address: PELLENSTRAAT 7 city: LANDEN postcode: 3400 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.	BE (LANDEN)	participant	1˙263˙250.00
4	ROYAL FREE LONDON NHS FOUNDATION TRUST ROYAL FREE LONDON NHS FOUNDATION TRUST Organization address address: POND STREET HAMPSTEAD city: LONDON postcode: NW3 2QG website: http://www.royalfree.nhs.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (LONDON)	participant	433˙750.00
5	IBM IRELAND LIMITED IBM IRELAND LIMITED Organization address address: IBM House, Shelbourne Road city: Ballsbridge postcode: Dublin 4 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.	IE (Ballsbridge)	participant	261˙250.00
6	ALBUTEC GMBH ALBUTEC GMBH Organization address address: SCHILLINGALLEE 68 city: ROSTOCK postcode: 18057 website: www.albutec.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (ROSTOCK)	participant	204˙500.00
7	ASSISTANCE PUBLIQUE HOPITAUX DE PARIS ASSISTANCE PUBLIQUE HOPITAUX DE PARIS Organization address address: 3 AVENUE VICTORIA city: PARIS postcode: 75000 website: http://www.aphp.fr contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (PARIS)	participant	176˙000.00
8	UNIVERSITATSMEDIZIN ROSTOCK UNIVERSITATSMEDIZIN ROSTOCK Organization address address: SCHILLINGALLEE 35 city: ROSTOCK postcode: 18055 website: www.med.uni-rostock.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (ROSTOCK)	participant	140˙125.00
9	EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF) EUROPEAN FOUNDATION FOR THE STUDY OF CHRONIC LIVER FAILURE (EF-CLIF) Organization address address: TRAVESSERA DE GRACIA 11, 7TH FLOOR city: BARCELONA postcode: 8021 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.	ES (BARCELONA)	participant	120˙500.00
10	SERVICIO MADRILENO DE SALUD SERVICIO MADRILENO DE SALUD Organization address address: PLAZA CARLOS TRIAS BERTRAN 7 city: MADRID postcode: 28020 website: http://cort.as/10Yf contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	ES (MADRID)	participant	116˙000.00
11	EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER EUROPEAN ASSOCIATION FOR THE STUDYOF THE LIVER Organization address address: LOWENSTRASSE 1 city: ZURICH postcode: 8001 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.	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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