Clinical trial • Phase III • Haematology|Rare Disease
Inno8 for Haemophilia A|Haemophilia A with inhibitors
Phase III trial of Inno8 for Haemophilia A|Haemophilia A with inhibitors. 21 participants.
Overview
- Trial Therapeutic Area
- Haematology|Rare Disease
- Trial Disease
- Haemophilia A|Haemophilia A with inhibitors
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 30-05-2025
- First CTIS Authorization Date
- 22-09-2025
Recruitment
- Planned Sample Size
- 21
- Recruitment Window Months
- 13
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 21
Austria
- Earliest CTIS Part Ii Submission Date
- 11-08-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 189
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Univ.-Klinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
- Contact Person Name
- Cihan Ay
- Contact Person Email
- cihan.ay@meduniwien.ac.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Univ.-Klinik für Innere Medizin V, Hämatologie und Onkologie
- Contact Person Name
- Clemens Feistritzer
- Contact Person Email
- Clemens.Feistritzer@i-med.ac.at
Germany
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 252
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Vivantes Berlin-Friedrichshain, Innere Medizin VI
- Contact Person Name
- Robert Klamroth
- Contact Person Email
- robert.klamroth@vivantes.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Haematologie, Gerinnungsambulanz
- Contact Person Name
- Andreas Tiede
- Contact Person Email
- Tiede.Andreas@mh-hannover.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Institut für Experimentelle Hämatologie
- Contact Person Name
- Johannes Oldenburg
- Contact Person Email
- johannes.oldenburg@ukbonn.de
Italy
- Earliest CTIS Part Ii Submission Date
- 02-09-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 162
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Contact Person Name
- Giancarlo Castaman
- Contact Person Email
- castaman@aou-careggi.toscana.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Contact Person Name
- Matteo Di Minno
- Contact Person Email
- matteo.diminno@unina.it
Spain
- Earliest CTIS Part Ii Submission Date
- 18-08-2025
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 263
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Contact Person Name
- Olga Benitez Hidalgo
- Contact Person Email
- olga.benitez@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Contact Person Name
- Santiago Bonanad Boix
- Contact Person Email
- bonanad_san@gva.es
- Site Name
- Hospital Universitario De Salamanca
- Contact Person Name
- Jose María Bastida Bermejo
- Contact Person Email
- jmbastida@saludcastillayleon.es
- Site Name
- Hospital Universitario La Paz
- Contact Person Name
- Víctor Jiménez Yuste
- Contact Person Email
- vjimenez.hulp@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Contact Person Name
- Francisco Lopez Jaime
- Contact Person Email
- franlopezjaime@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 09-09-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 160
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Contact Person Name
- Andrzej Mital
- Contact Person Email
- amital@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Hematologii, Ch. Wewn. i Angiologii z Pododdziałem Transplantacji Komórek Krwiotwórczych
- Contact Person Name
- Jarosław Piszcz
- Contact Person Email
- jaroslaw.piszcz@gmail.com
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych
- Contact Person Name
- Jerzy Windyga
- Contact Person Email
- jwindyga@ihit.waw.pl
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Investigational products
- Investigational Product Name
- Inno8
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