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

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.

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Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

AKH - Klin. Abt. f. Haematologie u. Haemostaseologie, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

Count of events

Secondary outcomes

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

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

Count of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: pathfinder9

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Oct 5, 2020
Registry last updated: Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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