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A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
Sponsor: Novo Nordisk A/S
Summary
This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
Official title: A Multinational, Prospective, Open Labelled, Non-controlled, Non-interventional Post-authorisation Study of Turoctocog Alfa Pegol (N8-GP) During Long-term Routine Prophylaxis and Treatment of Bleeding Episodes in Patients With Haemophilia A
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2020-10-23
Completion Date
2027-06-03
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
Turoctocog alfa pegol (N8-GP)
Patients will be treated with commercially available N8-GP for prophylaxis and treatment of bleeding episodes according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available N8-GP has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
Locations (27)
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, Austria
UMHAT "Tsaritsa Yoanna-ISUL"
Sofia, Bulgaria
KBC Zagreb, Rebro, Hemofilija centar
Zagreb, Croatia
FN Brno odd. hematologie
Brno, Czechia
FN HK - IV. Interni hematologicka klinika
Hradec Králové, Czechia
North Estonia Medical Centre Foundation
Tallinn, Estonia
Tartu University Hospital Haematology Clinic
Tartu, Estonia
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, Germany
"Laiko" General Hospital of Athens
Athens, Greece
"Laiko" General Hospital of Athens
Athens, Greece
Aghia Sophia Childrens' Hospital
Athens, Greece
MH Eü. Központ -Orszagos Haemophilia Kozpont
Budapest, Hungary
Azienda Ospedaliera-Universitaria Parma
Parma, Italy
Policlinico Umberto I Sezione Ematologia
Roma, Italy
A.O.U Città Salute Scienza Torino
Torino, Italy
Ospedale San Bortolo
Vicenza, Italy
Hospital of LUHS "Kauno Klinikos"
Kaunas, Lithuania
Republican Panevezys Hospital, Public consultation clinic
Panevezys, Lithuania
Vilnius University hospital Santaros klinikos
Vilnius, Lithuania
Vilnius University hospital Santaros klinikos
Vilnius, Lithuania
Centro Hospitalar Lisboa Norte-HSM
Lisbon, Portugal
ULS São João, E.P.E.
Porto, Portugal
Unilabs Slovensko, s. r. o.
Košice, Slovakia
PeK - University Children's Hospital, Department of haematology
Ljubljana, Slovenia
Hospital Regional Universitario de Málaga
Málaga, Spain
Kinderspital Hämatologie, Zürich
Zurich, Switzerland