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Enrolling by invitationNo phase

Following males with haemophilia A on long-term Esperoct prophylaxis

Collects side effects and how well Esperoct works in males with haemophilia A.

Key facts

Who runs it
Novo Nordisk A/S
Where
Sofia, BulgariaSee the siteAlso in 14 other countries, 24 sites
Trial code
Registry title
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
Status
Enrolling by invitation
People taking part
60 people, planned
Started
23 Oct 2020
Expected to end
3 Jun 2027
Type of study
Observational
Treatments tested
  • Turoctocog alfa pegol (N8-GP)
Record updated
22 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for males with moderate or severe haemophilia A who are starting treatment with Esperoct®. The study follows how well it works and any side effects over several years.

Age
Males of all ages, according to the local label.
Sex
Male only.
Disease stage
Severe or moderate haemophilia A.
Earlier treatment
The patient and doctor have decided to start Esperoct® on their own, before and apart from the decision to join this study.

Main reasons for not taking part

  • Took part in this study before
  • Known or suspected allergy to N8-GP or related products
  • Mental incapacity, unwillingness or language barriers that prevent understanding and cooperation
  • Suspected or present FVIII inhibitors when joining

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Known or suspected hypersensitivity to N8-GP or related products
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding and cooperation

Where in Bulgaria

Also in 14 other countries, 24 sites

  • UMHAT Tsaritsa Yoanna - ISULSofia, BulgariaNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • N8-GP

    Patients with haemophilia A

    Treatment: Turoctocog alfa pegol (N8-GP)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Following males with haemophilia A on long-term Esperoct prophylaxisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 December 2025