Clinical trial • Phase III • Immunology|Rare Disease
Clinical trial in Type I interferonopathies
Phase III trial for Type I interferonopathies. 9 participants.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Type I interferonopathies
- Trial Stage
- Phase III
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 06-11-2024
- First CTIS Authorization Date
- 07-03-2025
Eligibility
Recruits 9 paediatric patients.
- Vulnerable Population
- Vulnerable population selected (paediatric subjects). No consent/assent details provided in the record.
Recruitment
- Recruitment Window Months
- 17
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 9
Spain
- Earliest CTIS Part Ii Submission Date
- 06-03-2025
- Latest Decision Or Authorization Date
- 11-03-2025
- Processing Time Days
- 5
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Reumatología Pediátrica
- Principal Investigator Name
- Ángel Robles Marhuenda
- Principal Investigator Email
- aroblesmarhuenda@gmail.com
- Contact Person Name
- Ángel Robles Marhuenda
- Contact Person Email
- aroblesmarhuenda@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Unidad de enfermedades infecciosas e inmunodeficiencias
- Principal Investigator Name
- Mireia López-Corbeto
- Principal Investigator Email
- mireia.lopez@vhir.org
- Contact Person Name
- Mireia López-Corbeto
- Contact Person Email
- mireia.lopez@vhir.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Pediatría
- Principal Investigator Name
- José Salvador García Morillo
- Principal Investigator Email
- salvaymar@gmail.com
- Contact Person Name
- José Salvador García Morillo
- Contact Person Email
- salvaymar@gmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-01-2025
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 49
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Serviço Reumatologia
- Principal Investigator Name
- Filipa Oliveira Ramos
- Principal Investigator Email
- filipa.o.ramos@gmail.com
- Contact Person Name
- Filipa Oliveira Ramos
- Contact Person Email
- filipa.o.ramos@gmail.com
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Neurology department
- Principal Investigator Name
- Marina Magalhães
- Principal Investigator Email
- marinamagalhaes.neurologia@chporto.min-saude.pt
- Contact Person Name
- Marina Magalhães
- Contact Person Email
- marinamagalhaes.neurologia@chporto.min-saude.pt
Italy
- Earliest CTIS Part Ii Submission Date
- 19-12-2024
- Latest Decision Or Authorization Date
- 11-03-2025
- Processing Time Days
- 82
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
- Department Name
- SC (UCO) Medicina Clinica
- Principal Investigator Name
- Giacomo EMMI
- Principal Investigator Email
- giacomo.emmi@asugi.sanita.fvg.it
- Contact Person Name
- Giacomo EMMI
- Contact Person Email
- giacomo.emmi@asugi.sanita.fvg.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- DSCS UO Neuropsichiatria Infantile
- Principal Investigator Name
- Jessica GALLI
- Principal Investigator Email
- jessica.galli@unibs.it
- Contact Person Name
- Jessica GALLI
- Contact Person Email
- jessica.galli@unibs.it
France
- Earliest CTIS Part Ii Submission Date
- 19-12-2024
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 78
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service Médecine Interne
- Principal Investigator Name
- Sophie Georgin Lavialle
- Principal Investigator Email
- sophie.georgin-lavialle@aphp.fr
- Contact Person Name
- Sophie Georgin Lavialle
- Contact Person Email
- sophie.georgin-lavialle@aphp.fr
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- Centre d'Investigation Clinique
- Principal Investigator Name
- Marie-Louise Fremond
- Principal Investigator Email
- marie-louise.fremond@aphp.fr
- Contact Person Name
- Marie-Louise Fremond
- Contact Person Email
- marie-louise.fremond@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Centre d’Investigation Clinique
- Principal Investigator Name
- Agathe Roubertie
- Principal Investigator Email
- a-roubertie@chu-montpellier.fr
- Contact Person Name
- Agathe Roubertie
- Contact Person Email
- a-roubertie@chu-montpellier.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 07-10-2025
- Latest Decision Or Authorization Date
- 20-11-2025
- Processing Time Days
- 44
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Neurologie
- Principal Investigator Name
- Dimitri Hemelsoet
- Principal Investigator Email
- dimitri.hemelsoet@uzgent.be
- Contact Person Name
- Dimitri Hemelsoet
- Contact Person Email
- dimitri.hemelsoet@uzgent.be
Germany
- Earliest CTIS Part Ii Submission Date
- 14-02-2025
- Latest Decision Or Authorization Date
- 07-03-2025
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 2
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Universitäts-Hautklinik
- Principal Investigator Name
- Claudia Günther
- Principal Investigator Email
- Claudia.Guenther@med.uni-tuebingen.de
- Contact Person Name
- Claudia Günther
- Contact Person Email
- Claudia.Guenther@med.uni-tuebingen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Dermatologie
- Principal Investigator Name
- Claudia Günther
- Principal Investigator Email
- claudia.guenther@ukdd.de
- Contact Person Name
- Claudia Günther
- Contact Person Email
- claudia.guenther@ukdd.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie
- Principal Investigator Name
- Martin Wetzke
- Principal Investigator Email
- wetzke.martin@mh-hannover.de
- Contact Person Name
- Martin Wetzke
- Contact Person Email
- wetzke.martin@mh-hannover.de
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
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