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Japanese study tracks Esperoct's Real-World safety over two years

NCT ID NCT04334057

Knowledge-focused 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 watched 23 people with hemophilia A who were already using Esperoct as part of their normal care. Researchers tracked side effects and how well the medicine worked over about two years. The goal was to confirm the drug's safety and effectiveness in everyday use, not to test a new treatment.

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

23 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2024

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

Haemophilia A patients in routine clinical practice in Japan

Ages

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

Sex

Anyone

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. * Diagnosis of haemophilia A in males or females, no age limitation. * New patients who have not previously been exposed to Esperoct®. Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study. * Known or suspected hypersensitivity to study product or related products. * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

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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

Contacts and locations

Locations

  • Gifu University Hospital

    Gifu, 501-1194, Japan

  • Gifu University Hospital_The Third Dept. of Internal Medicine

    Gifu, 501-1194, Japan

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011, Japan

  • Lake Children Clinic

    Shiga, 520-2145, Japan

  • Nanbu Medical Center & Children's Medical Center_Pediatric Hematology

    Okinawa, 901-1193, Japan

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • Nihonkai Sogo Hospital

    Yamagata, 998-8501, Japan

  • Nihonkai Sogo Hospital_Internal Medicine

    Yamagata, 998-8501, Japan

  • Nippon Medical School Hospital_Haematology

    Tokyo, 113-8603, Japan

  • Ogikubo Hospital_Blood Coagulation

    Tokyo, 167-0035, Japan

  • Saitama Medical University Hospital, Pediatrics

    Iruma-gun, Saitama, 350 0495, Japan

  • Shibuya Children's Clinic, Department of Pediatric

    Saitama, 350-0225, Japan

  • Shizuoka Children's Hospital

    Shizuoka, 420-8660, Japan

  • Shizuoka Children's Hospital, Hematology-Oncology

    Shizuoka, 420-8660, Japan

  • St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,

    Yokohama-shi, Kanagawa, 241-0811, Japan

  • St. Marianna University School of Medicine Hospital

    Kanagawa, 216-8511, Japan

  • St. Marianna University School of Medicine Hospital_Pediatrics

    Kanagawa, 216-8511, Japan

  • Tokyo Medical Univ. Hospital

    Tokyo, 160-0023, Japan

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023, Japan

  • University Hospital Kyoto Prefectual University of Medicine

    Kamigyo-ku, Kyoto, 602-8566, Japan

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