Haemophilia Apathfinder9NCT04574076
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
An observational study of Haemophilia A, run by Novo Nordisk A/S at 27 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Haemophilia A
- What is being tested?
- Turoctocog alfa pegol (N8-GP)
- How many people
- 60 participants
- Where
- 27 sitesin 15 countries
- Study dates
- 23 Oct 2020to 3 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with haemophilia A
Who may be able to join
- 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 join
- 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
Trial locations and contacts
27 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
27 sites in 15 countries
Italy4 sites
Azienda Ospedaliera-Universitaria Parma
Parma, 43126
Policlinico Umberto I Sezione Ematologia
Roma, 00161
A.O.U Città Salute Scienza Torino
Torino, 10126
Ospedale San Bortolo
Vicenza, 36100
Lithuania4 sites
Hospital of LUHS "Kauno Klinikos"
Kaunas, LT-50161
Republican Panevezys Hospital, Public consultation clinic
Panevezys, LT-35144
Vilnius University hospital Santaros klinikos
Vilnius, 08661
Vilnius University hospital Santaros klinikos
Vilnius, LT-08661
Greece3 sites
"Laiko" General Hospital of Athens
Athens, 11527
"Laiko" General Hospital of Athens
Athens, GR-11527
Aghia Sophia Childrens' Hospital
Athens, GR-11527
Czechia2 sites
FN Brno odd. hematologie
Brno, 625 00
FN HK - IV. Interni hematologicka klinika
Hradec Králové, 500 05
Estonia2 sites
North Estonia Medical Centre Foundation
Tallinn, 13419
Tartu University Hospital Haematology Clinic
Tartu, 50406
Germany2 sites
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain
Berlin, 10249
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, 53127
Portugal2 sites
Centro Hospitalar Lisboa Norte-HSM
Lisbon, 1649-035
ULS São João, E.P.E.
Porto, 4200-319
Austria1 site
AKH - Klin. Abt. f. Haematologie u. Haemostaseologie
Vienna, 1090
Slovenia1 site
PeK - University Children's Hospital, Department of haematology
Ljubljana, 1000
About this study
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
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.
- Conditions
- Haemophilia A
- Being tested
- Turoctocog alfa pegol (N8-GP)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| N8-GP | Patients with haemophilia A Receives: Drug: Turoctocog alfa pegol (N8-GP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs) reported during the study period
Count of events
Measured: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years
Secondary outcomes (1)
Number of Serious Adverse Events (SAEs) reported during the study period
Count of events
Measured: From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start23 Oct 2020
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574076
- Sponsor's protocol ID
- NN7088-4029
- Other IDs
- EUPAS36536, U1111-1235-6007
- Acronym
- pathfinder9
- Status last verified
- Dec 2025
- First submitted
- 21 Sep 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04574076
- Acronym / sponsor ID
- pathfinder9 / NN7088-4029
- Conditions
- Haemophilia A
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N8-GP | – | Drug: Turoctocog alfa pegol (N8-GP)Patients with haemophilia A |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with haemophilia A
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | N8-GP |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (1452) study director
Novo Nordisk A/S
27 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A, run by Novo Nordisk A/S at 27 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy, Lithuania, Greece, Czechia, Estonia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.