Clinical trial • Phase II • Haematology|Rare Disease
efanesoctocog alfa for Haemophilia A|Severe haemophilia A
Phase II trial of efanesoctocog alfa for Haemophilia A|Severe haemophilia A. 36 participants.
Overview
- Trial Therapeutic Area
- Haematology|Rare Disease
- Trial Disease
- Haemophilia A|Severe haemophilia A
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 23-11-2023
- First CTIS Authorization Date
- 03-04-2024
Trial design
Phase II trial across 9 sites in Germany, Italy, Spain and others.
- Target Sample Size
- 36
Eligibility
Recruits 36 No vulnerable populations selected..
- Vulnerable Population
- No vulnerable populations selected.
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 36
Germany
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 05-04-2024
- Processing Time Days
- 74
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Hematology
- Principal Investigator Name
- Wolfgang Miesbach
- Principal Investigator Email
- Wolfgang.Miesbach@kgu.de
- Contact Person Name
- Wolfgang Miesbach
- Contact Person Email
- Wolfgang.Miesbach@kgu.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Experimental Haematology and Transfusion Medicine
- Principal Investigator Name
- Johannes Oldenburg
- Principal Investigator Email
- johannes.oldenburg@ukbonn.de
- Contact Person Name
- Johannes Oldenburg
- Contact Person Email
- johannes.oldenburg@ukbonn.de
Italy
- Earliest CTIS Part Ii Submission Date
- 13-12-2023
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 113
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Unit of Innovative Therapies for Genetic and Metabolic Diseases
- Principal Investigator Name
- Matteo Di Minno
- Principal Investigator Email
- matteo.diminno@unina.it
- Contact Person Name
- Matteo Di Minno
- Contact Person Email
- matteo.diminno@unina.it
- Site Name
- Humanitas Research Hospital
- Department Name
- Phase I Unit
- Principal Investigator Name
- Maria Elisa Mancuso
- Principal Investigator Email
- mariaelisa.mancuso@humanitas.it
- Contact Person Name
- Maria Elisa Mancuso
- Contact Person Email
- mariaelisa.mancuso@humanitas.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Center for Bleeding Clinical Trial Unit-1 (CTU-1)
- Principal Investigator Name
- Giancarlo Castaman
- Principal Investigator Email
- castaman@aou-careggi.toscana.it
- Contact Person Name
- Giancarlo Castaman
- Contact Person Email
- castaman@aou-careggi.toscana.it
Spain
- Earliest CTIS Part Ii Submission Date
- 05-03-2024
- Latest Decision Or Authorization Date
- 03-04-2024
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Hospital Unviersitario Miguel Servet
- Department Name
- Hematology and Hemotherapy Department
- Principal Investigator Name
- Jose Manuel Calvo Villas
- Principal Investigator Email
- jmcvillas@hotmail.com
- Contact Person Name
- Jose Manuel Calvo Villas
- Contact Person Email
- jmcvillas@hotmail.com
- Site Name
- Complejo Hospitalario Universitario Juan Canalejo
- Department Name
- Hematology
- Principal Investigator Name
- Marta Fernandez Docampo
- Principal Investigator Email
- Marta.Fernandez.Docampo@sergas.es
- Contact Person Name
- Marta Fernandez Docampo
- Contact Person Email
- Marta.Fernandez.Docampo@sergas.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hemostasis and Thrombosis Unit
- Principal Investigator Name
- Haya Guaita Saturnino
- Principal Investigator Email
- hagusat@gmail.com
- Contact Person Name
- Haya Guaita Saturnino
- Contact Person Email
- hagusat@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 69
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Specialized Hospital For Active Treatment Of Hematological Diseases EAD
- Department Name
- Third Department of Clinical Hematology at Clinical Hematology Clinic
- Principal Investigator Name
- Toshko Lissitchkov
- Principal Investigator Email
- t_lissitchkov@yahoo.com
- Contact Person Name
- Toshko Lissitchkov
- Contact Person Email
- t_lissitchkov@yahoo.com
Sponsor
Primary sponsor
- Full Name
- Swedish Orphan Biovitrum AB (publ)
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- efanesoctocog alfa
- Active Substance
- efanesoctocog alfa
- Modality
- Peptide/protein/enzyme
- Investigational Product Name
- Other EHL-rFVIII products
- Active Substance
- recombinant factor VIII (rFVIII) - extended half-life products
- Modality
- Peptide/protein/enzyme
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