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Hemophilia a patients monitored for 5 years on esperoct

NCT ID NCT04574076

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 60 males with hemophilia A who are already using Esperoct to prevent bleeds. Researchers will track side effects and how well the medicine controls bleeding over 5-7 years. Participants continue their normal treatment and clinic visits, with no extra procedures required.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with haemophilia A

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Laiko" General Hospital of Athens

    Athens, 11527, Greece

  • "Laiko" General Hospital of Athens

    Athens, GR-11527, Greece

  • A.O.U Città Salute Scienza Torino

    Torino, 10126, Italy

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    Vienna, 1090, Austria

  • Aghia Sophia Childrens' Hospital

    Athens, GR-11527, Greece

  • Azienda Ospedaliera-Universitaria Parma

    Parma, 43126, Italy

  • Centro Hospitalar Lisboa Norte-HSM

    Lisbon, 1649-035, Portugal

  • FN Brno odd. hematologie

    Brno, 625 00, Czechia

  • FN HK - IV. Interni hematologicka klinika

    Hradec Králové, 500 05, Czechia

  • Hospital Regional Universitario de Málaga

    Málaga, 29009, Spain

  • Hospital of LUHS "Kauno Klinikos"

    Kaunas, LT-50161, Lithuania

  • KBC Zagreb, Rebro, Hemofilija centar

    Zagreb, 10 000, Croatia

  • Kinderspital Hämatologie, Zürich

    Zurich, 8032, Switzerland

  • MH Eü. Központ -Orszagos Haemophilia Kozpont

    Budapest, H-1134, Hungary

  • North Estonia Medical Centre Foundation

    Tallinn, 13419, Estonia

  • Ospedale San Bortolo

    Vicenza, 36100, Italy

  • PeK - University Children's Hospital, Department of haematology

    Ljubljana, 1000, Slovenia

  • Policlinico Umberto I Sezione Ematologia

    Roma, 00161, Italy

  • Republican Panevezys Hospital, Public consultation clinic

    Panevezys, LT-35144, Lithuania

  • Tartu University Hospital Haematology Clinic

    Tartu, 50406, Estonia

  • ULS São João, E.P.E.

    Porto, 4200-319, Portugal

  • UMHAT "Tsaritsa Yoanna-ISUL"

    Sofia, 1527, Bulgaria

  • Unilabs Slovensko, s. r. o.

    Košice, 04011, Slovakia

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    Bonn, 53127, Germany

  • Vilnius University hospital Santaros klinikos

    Vilnius, 08661, Lithuania

  • Vilnius University hospital Santaros klinikos

    Vilnius, LT-08661, Lithuania

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

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