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HIT-CF SIGNED

Personalised Treatment For Cystic Fibrosis Patients With Ultra-rare CFTR Mutations (and beyond)

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

HIT-CF project word cloud

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

implements grown meta armed reimbursement group efficacy otherwise label market proven intestinal cf fibrosis cystic groups miniature patient placebo personalised medicine treatments shift blind extend compound double managed acquire methodology rectal personalized genotyping instead shifting laboratory goals designed gene treatment crossover parallel modifying paradigm prospectively cftr global never termed trial therapeutic organs platform mutations candidates prospective easily off cultured gating organoids pharmaceutical hit biopsies rare repeated once therapies randomised ultra candidate single organoid assigned disease effect drug impacts entire f508del arm therapy people individual innovative trials individuals approval obtain community ultimately combination patients

Project "HIT-CF" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITAIR MEDISCH CENTRUM UTRECHT Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX website: www.umcutrecht.nl 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	Netherlands [NL]
Project website	https://www.hitcf.org/
Total cost	8˙753˙615 €
EC max contribution	6˙701˙365 € (77%)
Programme	1. H2020-EU.3.1.3. (Treating and managing disease)
Code Call	H2020-SC1-2017-Two-Stage-RTD
Funding Scheme	RIA
Starting year	2018
Duration (year-month-day)	from 2018-01-01 to 2022-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITAIR MEDISCH CENTRUM UTRECHT UNIVERSITAIR MEDISCH CENTRUM UTRECHT Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX website: www.umcutrecht.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	coordinator	1˙434˙417.00
2	JULIUS CLINICAL RESEARCH BV JULIUS CLINICAL RESEARCH BV Organization address address: BROEDERPLEIN 41-43 city: ZEIST postcode: 3703 CD website: www.juliusclinical.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (ZEIST)	participant	2˙703˙152.00
3	STICHTING HUBRECHT ORGANOID TECHNOLOGY STICHTING HUBRECHT ORGANOID TECHNOLOGY Organization address address: YALELAAN 62 city: UTRECHT postcode: 3584 CM 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.	NL (UTRECHT)	participant	1˙088˙050.00
4	KATHOLIEKE UNIVERSITEIT LEUVEN KATHOLIEKE UNIVERSITEIT LEUVEN Organization address address: OUDE MARKT 13 city: LEUVEN postcode: 3000 website: www.kuleuven.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (LEUVEN)	participant	386˙250.00
5	EUROPEAN CYSTIC FIBROSIS SOCIETY EUROPEAN CYSTIC FIBROSIS SOCIETY Organization address address: KASTANIEPARKEN 7 city: KARUP postcode: 7470 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.	DK (KARUP)	participant	334˙740.00
6	PATERGRUS BVBA PATERGRUS BVBA Organization address address: SPARHOEKDREEF 57 city: AALTER postcode: 9880 website: www.biotechsubsidy.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (AALTER)	participant	302˙075.00
7	FCIENCIAS.ID - ASSOCIACAO PARA A INVESTIGACAO E DESENVOLVIMENTO DE CIENCIAS FCIENCIAS.ID - ASSOCIACAO PARA A INVESTIGACAO E DESENVOLVIMENTO DE CIENCIAS Organization address address: CAMPO GRANDE, EDIFICIO C1, PISO 3 city: LISBON postcode: 1749 016 website: http://www.fciencias-id.pt contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	PT (LISBON)	participant	257˙367.00
8	CYSTIC FIBROSIS EUROPE EV CYSTIC FIBROSIS EUROPE EV Organization address address: IN DEN DAUEN 6 city: BONN postcode: 53117 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.	DE (BONN)	participant	141˙312.00
9	FLATLEY DISCOVERY LAB LLC FLATLEY DISCOVERY LAB LLC Organization address address: 45 Dan Road, Suite 320 city: CANTON, MASSACHUSETTS postcode: 2021 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.	US (CANTON, MASSACHUSETTS)	participant	27˙000.00
10	GALAPAGOS GALAPAGOS Organization address address: GENERAAL DE WITTELAAN L11 A3 city: MECHELEN postcode: 2800 website: www.glpg.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (MECHELEN)	participant	27˙000.00

Map

Project objective

In our HIT-CF project, we aim to bring personalised disease modifying therapies to cystic fibrosis (CF) patients with ultra-rare CFTR mutations, who could otherwise never get access to such treatment. Once we have proven our unique concept, the CF community can easily extend our state-of-the-art methodology to all CF patients such that HIT-CF will impact the entire CF field.

We will achieve our goals by means of a randomised, double-blind, placebo-controlled, repeated-crossover, three-armed platform trial with prospectively defined meta-analysis to evaluate efficacy at group and individual level. HIT-CF is designed to enable access to the most relevant global drug products, and each trial arm will test a drug product candidate (a single compound or a compound combination) from one of our pharmaceutical consortium partners. The patients will be assigned to the specific trial based on the effect of the drug product candidates on cultured intestinal miniature organs (termed organoids) grown from rectal biopsies, instead of based on typical genotyping only. In parallel with this H2020 project, our pharmaceutical partners will obtain market approval of their drug product candidates for common (F508del or gating) mutations in the CFTR gene. Ultimately, our project will enable ‘managed’ off-label access to these therapies towards patient groups or individuals who show response to the therapy in a prospective intestinal organoid test.

One of the major impacts of this project will be the innovative methodologies to acquire reimbursement for current and future off-label treatments of people with CFTR mutations. This will represent a real paradigm shift in CF treatment as it implements a new type of personalized medicine paradigm based on organoids, by shifting therapeutic trials from patients to the laboratory.

Deliverables

List of deliverables.
A suite of branded template material and a website	Other	2019-11-08 11:12:33

Take a look to the deliverables list in detail: detailed list of HIT-CF deliverables.

Are you the coordinator (or a participant) of this project? Plaese send me more information about the "HIT-CF" project.

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Send me an email (fabio@fabiodisconzi.com) and I put them in your project's page as son as possible.

Thanks. And then put a link of this page into your project's website.

The information about "HIT-CF" are provided by the European Opendata Portal: CORDIS opendata.