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HIT-CF SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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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 NL (UTRECHT) coordinator 1˙434˙417.00
2    JULIUS CLINICAL RESEARCH BV NL (ZEIST) participant 2˙703˙152.00
3    STICHTING HUBRECHT ORGANOID TECHNOLOGY NL (UTRECHT) participant 1˙088˙050.00
4    KATHOLIEKE UNIVERSITEIT LEUVEN BE (LEUVEN) participant 386˙250.00
5    EUROPEAN CYSTIC FIBROSIS SOCIETY DK (KARUP) participant 334˙740.00
6    PATERGRUS BVBA BE (AALTER) participant 302˙075.00
7    FCIENCIAS.ID - ASSOCIACAO PARA A INVESTIGACAO E DESENVOLVIMENTO DE CIENCIAS PT (LISBON) participant 257˙367.00
8    CYSTIC FIBROSIS EUROPE EV DE (BONN) participant 141˙312.00
9    FLATLEY DISCOVERY LAB LLC US (CANTON, MASSACHUSETTS) participant 27˙000.00
10    GALAPAGOS 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.

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

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