A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®

Last updated: April 3, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Enrolling

Phase

N/A

Condition

Hemophilia

Treatment

Turoctocog alfa pegol (N8-GP)

Clinical Study ID

NCT04574076
NN7088-4029
U1111-1235-6007
EUPAS36536
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-relatedactivities are any procedure related to recording of data according to theprotocol).

  • The decision to initiate treatment with commercially available Esperoct® has beenmade by the patient/Legally Acceptable Representative (LAR) and the treatingphysician before and independently from the decision to include the patient in thisstudy.

  • Male patients of all ages, according to local label, are allowed in this study

  • Diagnosis of severe or moderate Haemophilia A

Exclusion

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having giveninformed consent in this study

  • Known or suspected hypersensitivity to N8-GP or related products

  • Mental incapacity, unwillingness or language barriers precluding adequateunderstanding and cooperation

  • Clinical suspicion or presence of FVIII inhibitors at time of inclusion

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Turoctocog alfa pegol (N8-GP)
Phase:
Study Start date:
October 23, 2020
Estimated Completion Date:
June 03, 2027

Connect with a study center

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Wien, 1090
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Wien, 1090
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Sofia, 1527
    Bulgaria

    Site Not Available

  • UMHAT "Tsaritsa Yoanna-ISUL"

    Sofia, 1527
    Bulgaria

    Site Not Available

  • KBC Zagreb, Rebro, Hemofilija centar

    Zagreb, 10 000
    Croatia

    Site Not Available

  • Novo Nordisk Investigational Site

    Zagreb, 10 000
    Croatia

    Site Not Available

  • FN Brno odd. hematologie

    Brno, 625 00
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Brno, 625 00
    Czechia

    Site Not Available

  • FN HK - IV. Interni hematologicka klinika

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Novo Nordisk Investigational Site

    Bagsværd, 2880
    Denmark

    Site Not Available

  • North Estonia Medical Centre Foundation

    Tallinn, 13419
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Tallinn, 13419
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Tartu, 50406
    Estonia

    Site Not Available

  • Tartu University Hospital Haematology Clinic

    Tartu, 50406
    Estonia

    Site Not Available

  • Novo Nordisk Investigational Site

    Berlin, 10249
    Germany

    Site Not Available

  • Vivantes Klinikum am Friedrichshain

    Berlin, 10249
    Germany

    Site Not Available

  • Vivantes Klinikum am Friedrichshain - Innere Medizin - Angiologie und Hämostaseologie

    Berlin, 10249
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Bonn, 53127
    Germany

    Site Not Available

  • Rheinische Friedrich-Wilhelms-Universität Bonn

    Bonn, 53127
    Germany

    Site Not Available

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127
    Germany

    Site Not Available

  • "Laiko" General Hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • Aghia Sophia Childrens' Hospital

    Athens, GR-11527
    Greece

    Site Not Available

  • Novo Nordisk Investigational Site

    Athens, GR-11527
    Greece

    Site Not Available

  • MH Eü. Központ -Orszagos Haemophilia Kozpont

    Budapest, H-1134
    Hungary

    Site Not Available

  • Novo Nordisk Investigational Site

    Budapest, H-1134
    Hungary

    Site Not Available

  • Azienda Ospedaliera-Universitaria Parma

    Parma, 43126
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Parma, 43126
    Italy

    Site Not Available

  • A.O.U Città Salute Scienza Torino

    Torino, 10126
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Torino, 10126
    Italy

    Site Not Available

  • Novo Nordisk Investigational Site

    Vicenza, 36100
    Italy

    Site Not Available

  • Ospedale San Bortolo

    Vicenza, 36100
    Italy

    Site Not Available

  • Hospital of LUHS "Kauno Klinikos"

    Kaunas, LT-50161
    Lithuania

    Site Not Available

  • Novo Nordisk Investigational Site

    Kaunas, LT-50161
    Lithuania

    Site Not Available

  • Novo Nordisk Investigational Site

    Panevezys, LT-35144
    Lithuania

    Site Not Available

  • Republican Panevezys Hospital, Public consultation clinic

    Panevezys, LT-35144
    Lithuania

    Site Not Available

  • Novo Nordisk Investigational Site

    Vilnius, LT-08661
    Lithuania

    Site Not Available

  • Vilnius University hospital Santaros klinikos

    Vilnius, LT-08661
    Lithuania

    Site Not Available

  • Centro Hospitalar Lisboa Norte-HSM

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar de São João_Porto

    Porto, 4200-319
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Porto, 4200-319
    Portugal

    Site Not Available

  • ULS São João, E.P.E.

    Porto, 4200-319
    Portugal

    Site Not Available

  • Novo Nordisk Investigational Site

    Kosice, 04001
    Slovakia

    Site Not Available

  • Unilabs Slovensko, s. r. o.

    Kosice, 04011
    Slovakia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • PeK - University Children's Hospital, Department of haematology

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • Hospital Universitario Regional de Málaga

    Málaga, 29009
    Spain

    Site Not Available

  • Novo Nordisk Investigational Site

    Málaga, 29009
    Spain

    Site Not Available

  • Kinderspital Hämatologie, Zürich

    Zürich, 8032
    Switzerland

    Site Not Available

  • Novo Nordisk Investigational Site

    Zürich, 8032
    Switzerland

    Site Not Available

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