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

N/AEnrolling By InvitationNCT04574076

Novo Nordisk A/S60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Haemophilia A

Interventions

Turoctocog alfa pegol (N8-GP)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.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

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

...and 17 more locations

Outcomes

Primary Outcomes

Number of Adverse Events (AEs) reported during the study period

Count of events

Time frame: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years

Secondary Outcomes

Number of Serious Adverse Events (SAEs) reported during the study period

Count of events

Time frame: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years