NCT04574076Enrolling by invitation
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
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
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 21 Sept 2020
- Start date
- 23 Oct 2020
- Primary completion date
- 3 Jun 2027
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Haemophilia
- NCT number
- NCT04574076
What you commit to
- Study type: Observational
- Planned participants: 60
- From 23 Oct 2020 to the primary completion date, 3 Jun 2027
- 25 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Clinical suspicion or presence of FVIII inhibitors at time of inclusion
Other illness
- Known or suspected hypersensitivity to N8-GP or related products
Other
- Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation
Who the study is looking for
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available Esperoct® 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.
- Male patients of all ages, according to local label, are allowed in this study
- Diagnosis of severe or moderate Haemophilia A
Sex: Male · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AKH - Klin. Abt. f. Haematologie u. Haemostaseologie Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| UMHAT Tsaritsa Yoanna - ISUL Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Kinderspital Hämatologie, Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| FN Brno odd. hematologie Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| FN HK - IV. Interni hematologicka klinika Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Unknown status |
| Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| North Estonia Medical Centre Foundation Coordinator of this site? Confirm its status | Tallinn | Estonia | Unknown status |
| Tartu University Hospital Haematology Clinic Coordinator of this site? Confirm its status | Tartu | Estonia | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Aghia Sophia Childrens' Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| KBC Zagreb, Rebro, Hemofilija centar Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| MH Eü. Központ -Orszagos Haemophilia Kozpont Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Azienda Ospedaliera-Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Policlinico Umberto I Sezione Ematologia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U Città Salute Scienza Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedale San Bortolo Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
| Hospital of LUHS "Kauno Klinikos" Coordinator of this site? Confirm its status | Kaunas | Lithuania | Unknown status |
| Republican Panevezys Hospital, Public consultation clinic Coordinator of this site? Confirm its status | Panevezys | Lithuania | Unknown status |
| Vilnius University Hospital Santaros Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Unknown status |
| Centro Hospitalar Lisboa Norte-HSM Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| ULS São João, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| PeK - University Children's Hospital, Department of haematology Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
| Unilabs Slovensko, s. r. o. Coordinator of this site? Confirm its status | Košice | Slovakia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.