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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

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
UMHAT Tsaritsa Yoanna - ISUL
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Kinderspital Hämatologie, Zürich
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ZurichSwitzerlandUnknown status
FN Brno odd. hematologie
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
FN HK - IV. Interni hematologicka klinika
Coordinator of this site? Confirm its status
Hradec KrálovéCzechiaUnknown status
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
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BonnGermanyUnknown status
North Estonia Medical Centre Foundation
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TallinnEstoniaUnknown status
Tartu University Hospital Haematology Clinic
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TartuEstoniaUnknown status
Hospital Regional Universitario de Malaga
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MálagaSpainUnknown status
Aghia Sophia Childrens' Hospital
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AthensGreeceUnknown status
Laiko General Hospital of Athens
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AthensGreeceUnknown status
KBC Zagreb, Rebro, Hemofilija centar
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ZagrebCroatiaUnknown status
MH Eü. Központ -Orszagos Haemophilia Kozpont
Coordinator of this site? Confirm its status
BudapestHungaryUnknown status
Azienda Ospedaliera-Universitaria Parma
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ParmaItalyUnknown status
Policlinico Umberto I Sezione Ematologia
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RomaItalyUnknown status
A.O.U Città Salute Scienza Torino
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TorinoItalyUnknown status
Ospedale San Bortolo
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VicenzaItalyUnknown status
Hospital of LUHS "Kauno Klinikos"
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KaunasLithuaniaUnknown status
Republican Panevezys Hospital, Public consultation clinic
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PanevezysLithuaniaUnknown status
Vilnius University Hospital Santaros Klinikos
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VilniusLithuaniaUnknown status
Centro Hospitalar Lisboa Norte-HSM
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LisbonPortugalUnknown status
ULS São João, E.P.E.
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PortoPortugalUnknown status
PeK - University Children's Hospital, Department of haematology
Coordinator of this site? Confirm its status
LjubljanaSloveniaUnknown status
Unilabs Slovensko, s. r. o.
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KošiceSlovakiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.