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Japanese hemophilia patients monitored on alhemo in new safety study

NCT ID NCT06285071

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks the safety and effectiveness of the drug Alhemo (concizumab) in 23 people with hemophilia A or B in Japan. Participants receive the drug as part of their normal care, and researchers will monitor side effects for about 2 years. The goal is to see how well Alhemo works in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Concizumab (Alhemo)
What this could lead to
If successful, this study will confirm that Alhemo is safe and effective for routine use in people with hemophilia A or B in Japan.
What could go wrong
This is an observational study with only 23 participants, so results may not apply to everyone. It is not designed to prove new benefits, only to monitor real-world safety.

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 23 people

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

Started

Aug 2024

Expected to finish

Apr 2030

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

Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available concizumab according to routine clinical practice at the discretion of the treating physician.

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 Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study * Male or female patients, regardless of age * Diagnosis with HAwI/HBwI Exclusion Criteria: \- Previous participation in this study. Participation is defined as having given informed consent in this study

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Conditions

The condition(s) this trial relates to.

hemophilia A hemophilia B

As listed by the trial registrant

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

Haemophilia A Haemophilia B

How to take part

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

  1. The places running it

    11 sites. 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

  • Hospital of the University of Occupational And Environmental Health Japan_Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555, Japan

  • Kagoshima City Hospital_Pediatrics

    Kagoshima, 890-8760, Japan

  • Kyushu university hospital_Pediatrics

    Fukuoka, 812-8582, Japan

  • Mutsu general hospital_Pediatrics

    Aomori, 035-8601, Japan

  • Nanbu Medical Center & Children's Medical Center_Hematology and Oncology

    Okinawa, 901-1193, Japan

  • Novo Nordisk Investigational Site

    Toshima City, Tokyo, Japan

  • Ogikubo Hospital_Blood Coagulation

    Tokyo, 167-0035, Japan

  • Sapporo Tokushukai Hospital_Pediatrics

    Hokkaido, 004-0041, Japan

  • St. Marianna University School of Medicine Hospital_Pediatrics

    Kanagawa, 216-8511, Japan

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology

    Okinawa, 901-2725, Japan

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