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Japanese hemophilia b patients monitored on refixia – no surprises found

NCT ID NCT03875547

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 28 people with hemophilia B in Japan who were already prescribed Refixia as part of their normal care. Researchers tracked side effects, bleeding episodes, and quality of life to confirm the drug's safety and effectiveness over time. The study did not test a new treatment or aim for a cure, but rather checked how well the medicine works in everyday use.

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

28 people

The number who actually took part.

Started

Aug 2019

Finished

Sep 2025

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 B

Ages

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

Sex

Anyone

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 Refixia® 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. At each site of this study, all patients will be registered consecutively from the first patient after the launch of Refixia® (consecutively registered system). * Diagnosis of haemophilia B in males or females, no age limitation. Patients younger than 12 years old will continue to be registered for 3 years of recruitment period regardless of the target number of patients. * New patients who have not been previously exposed to Refixia®. Also patients previously exposed to Refixia® in NN7999-3639, -3747, -3774, -3775 or -3895 clinical trial can be enrolled in this study. The patients who have participated in NN7999 -3774 or -3895 clinical trial can be enrolled in this study as continuous cases until 30-September-2024 (one year before planned end of study date). Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Known or suspected hypersensitivity to study product or related products.

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Conditions

The condition(s) this trial relates to.

hemophilia B

As listed by the trial registrant

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

Haemophilia B

Contacts and locations

Locations

  • Aomori Prefectural Central Hospital_Pediatrics

    Aomori, 030-8553, Japan

  • Chiba University Hospital_Diabetes, Metabolism and Endocrinology

    Chiba-shi, Chiba, 260-8677, Japan

  • Gunma University Hospital_Hematology

    Maebashi-shi, Gunma, 371-8511, Japan

  • Hospital of the University of Occupational And Environmental Health Japan_Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555, Japan

  • Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy

    Hyōgo, 654-0047, Japan

  • Ishikawa Prefectural Central Hospital_Haematology

    Ishikawa, 920-8530, Japan

  • Ishiyama Clinic

    Yamagata, 992-0035, Japan

  • Japan Red Cross Narita Hospital_Hematology and Oncology

    Chiba, 286-8523, Japan

  • Kitasato University Hospital_Blood Transfusion

    Kanagawa, 252-0375, Japan

  • Matsudo City General Hospital_Pediatrics

    Chiba, 270-2296, Japan

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560, Japan

  • Naha City Hospital_Cardiovascular Medicine

    Naha-shi, Okinawa, 902-8511, Japan

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • Novo Nordisk Investigational Site

    Søborg, Denmark

  • Ogikubo Hospital_Blood Coagulation

    Tokyo, 167-0035, Japan

  • Saitama Children's Med Centre_Hematology-Oncology

    Saitama, 330-8777, Japan

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

    Yokohama-shi, Kanagawa, 241-0811, Japan

  • St. Marianna University School of Medicine Hospital_Pediatrics

    Kanagawa, 216-8511, Japan

  • The Hospital of Hyogo College of Medicine_Haematology

    Nishinomiya-shi, Hyogo, 663 8051, Japan

  • Tokushima Red Cross Hospital_Pediatrics

    Tokushima, 773-8502, Japan

  • Tokushima University Hospital_Pediatrics

    Tokushima, 770-8503, Japan

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023, Japan

  • Tokyo Medical University Ibaraki Medical Center_Ibaraki

    Ibaraki, 300-0395, Japan

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