Since the announcement of the conect4children (c4c) Consortium’s first portfolio of research studies in April 2019, it is with regret that we inform you the Matrix-directed therapy in children with osteogenesis imperfecta (MOI) study, will no longer feature as part of the c4c portfolio of studies.
The c4c Consortium undertook a competitive selection process of research studies in late 2018/early 2019 to identify clinical trials that investigate high priority medicines in children and young people in Europe. The MOI study was selected as part of c4c Consortium’s first research studies portfolio.
The MOI study aimed to assess Losartan in children and young people with Osteogenesis Imperfecta, led by Professor Nick Bishop of the University of Sheffield in the United Kingdom. Following the selection of the study for the c4c portfolio, the investigational product was withdrawn from the market, and with no alternative suitable liquid preparation available, it has not been possible to continue with the MOI study as part of the c4c Consortium’s research studies portfolio.
The c4c Consortium wish to thank the MOI team for all their efforts and involvement in the c4c project.
“We regret that the MOI study was unable to be initiated as planned due to concerns over sourcing an appropriate licenced liquid preparation after the commercial preparation was withdrawn in June of 2019. It proved impossible within the timelines of the c4c project to source an alternative liquid preparation for which a licence was in place, or for which the necessary regulatory approvals could be obtained, and then move on to undertake the study. The MOI study team hope to be able to continue to support the work of c4c in the future and valued the scientific input and responsiveness of the network in the time we were working together.” Professor Nick Bishop, University of Sheffield, UK.
Preparation is currently underway within the c4c Network for the opening of the remaining c4c Consortium’s portfolio of research studies in the coming months. Find out more about the c4c research studies portfolio below.
About the c4c pan-European paediatric studies:
- TREOCAPA. Paracetamol in Premature Babies: will assess the effectiveness of paracetamol on the closure of the ductus arteriosus and the increase in surviving without severe morbidity of extreme premature infants. The study aims to recruit around 800 babies in 17 European countries. (Lead: Prof. Jean-Christophe Roze of INSERM, a public research organization in Paris, France entirely dedicated to human health)
- KD-CAAP. Kawasaki Disease Coronary Artery Aneurysm Prevention trial: will assess the effectiveness of adding steroids to standard treatment in children with Kawasaki Disease, and aims to recruit 262 children as part of the study (Leads: Dr Despina Eleftheriou and Prof. Paul Brogan of the university College of London (UCL), an academic research institution in the UK.
- cASPerCF. Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. The study will assess the dose of posaconazole in children and young people with Cystic Fibrosis and Aspergillus infection and aims to recruit 135 children as part of the study (Lead: Prof Adilia Warris of the MRC Centre for Medical Mycology, University of Exeter, Sponsor: Ospedale Pediatrico Bambino Gesu (OPBG), a children’s hospital in Rome, Italy).