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

NCT ID: NCT04574076

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-23

Study Completion Date

2027-06-03

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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N8-GP

Patients with haemophilia A

Turoctocog alfa pegol (N8-GP)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Known or suspected hypersensitivity to N8-GP or related products
* Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation
* Clinical suspicion or presence of FVIII inhibitors at time of inclusion
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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

Vienna, , Austria

Site Status

UMHAT "Tsaritsa Yoanna-ISUL"

Sofia, , Bulgaria

Site Status

KBC Zagreb, Rebro, Hemofilija centar

Zagreb, , Croatia

Site Status

FN Brno odd. hematologie

Brno, , Czechia

Site Status

FN HK - IV. Interni hematologicka klinika

Hradec Králové, , Czechia

Site Status

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Site Status

Tartu University Hospital Haematology Clinic

Tartu, , Estonia

Site Status

Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Site Status

Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

Bonn, , Germany

Site Status

"Laiko" General Hospital of Athens

Athens, , Greece

Site Status

"Laiko" General Hospital of Athens

Athens, , Greece

Site Status

Aghia Sophia Childrens' Hospital

Athens, , Greece

Site Status

MH Eü. Központ -Orszagos Haemophilia Kozpont

Budapest, , Hungary

Site Status

Azienda Ospedaliera-Universitaria Parma

Parma, , Italy

Site Status

Policlinico Umberto I Sezione Ematologia

Roma, , Italy

Site Status

A.O.U Città Salute Scienza Torino

Torino, , Italy

Site Status

Ospedale San Bortolo

Vicenza, , Italy

Site Status

Hospital of LUHS "Kauno Klinikos"

Kaunas, , Lithuania

Site Status

Republican Panevezys Hospital, Public consultation clinic

Panevezys, , Lithuania

Site Status

Vilnius University hospital Santaros klinikos

Vilnius, , Lithuania

Site Status

Vilnius University hospital Santaros klinikos

Vilnius, , Lithuania

Site Status

Centro Hospitalar Lisboa Norte-HSM

Lisbon, , Portugal

Site Status

ULS São João, E.P.E.

Porto, , Portugal

Site Status

Unilabs Slovensko, s. r. o.

Košice, , Slovakia

Site Status

PeK - University Children's Hospital, Department of haematology

Ljubljana, , Slovenia

Site Status

Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status

Kinderspital Hämatologie, Zürich

Zurich, , Switzerland

Site Status

Countries

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Denmark Austria Bulgaria Croatia Czechia Estonia Germany Greece Hungary Italy Lithuania Portugal Slovakia Slovenia Spain Switzerland

Other Identifiers

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EUPAS36536

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1235-6007

Identifier Type: OTHER

Identifier Source: secondary_id

NN7088-4029

Identifier Type: -

Identifier Source: org_study_id