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

Haemophilia A Clinical Trial

— pathfinder9  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04574076
• Other study ID #: NN7088-4029
• Secondary ID: EUPAS36536U1111-
• Status: Enrolling by invitation
• Start date: October 23, 2020
• Est. completion date: June 3, 2027

Study information

• Verified date: December 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 3, 2027
• Est. primary completion date: June 3, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia A
• Hemophilia A

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Wien
Bulgaria	Novo Nordisk Investigational Site	Sofia
Croatia	Novo Nordisk Investigational Site	Zagreb
Czechia	Novo Nordisk Investigational Site	Brno
Czechia	Novo Nordisk Investigational Site	Hradec Kralove
Estonia	Novo Nordisk Investigational Site	Tallinn
Estonia	Novo Nordisk Investigational Site	Tartu
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Bonn
Greece	Novo Nordisk Investigational Site	Athens
Hungary	Novo Nordisk Investigational Site	Budapest
Italy	Novo Nordisk Investigational Site	Parma
Italy	Novo Nordisk Investigational Site	Torino
Italy	Novo Nordisk Investigational Site	Vicenza
Lithuania	Novo Nordisk Investigational Site	Kaunas
Lithuania	Novo Nordisk Investigational Site	Panevezys
Lithuania	Novo Nordisk Investigational Site	Vilnius
Portugal	Novo Nordisk Investigational Site	Lisboa
Portugal	Novo Nordisk Investigational Site	Porto
Slovakia	Novo Nordisk Investigational Site	Kosice
Slovenia	Novo Nordisk Investigational Site	Ljubljana
Spain	Novo Nordisk Investigational Site	Málaga
Switzerland	Novo Nordisk Investigational Site	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events (AEs) reported during the study period	Count of events	From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years
Secondary	Number of Serious Adverse Events (SAEs) reported during the study period	Count of events	From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years