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New study tracks Alhemo's Real-World safety in hemophilia patients

NCT ID NCT06831734

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30 people with hemophilia A or B (without inhibitors) in Japan who are already using Alhemo (concizumab) as part of their routine care. Researchers will monitor side effects and how well the drug works over about 2 years per person. The goal is to see if Alhemo remains safe and effective 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 could confirm that Alhemo is safe and effective for long-term use in people with hemophilia A or B without inhibitors, supporting its routine use.
What could go wrong
This is an observational study with only 30 participants, so results may not apply to everyone. It does not test a new treatment, just monitors existing use, and unexpected side effects could still emerge.

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 30 people

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

Started

May 2025

Expected to finish

Jan 2031

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 without inhibitors will be be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician.

Ages

12 years and older

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 Alhemo has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study. * Male or female, age above or equal to 12 years at the time of signing informed consent. * Diagnosis with Haemophilia A (HA) or Haemophilia B (HB). * Participant who has never been exposed to concizumab or who starts treatment with concizumab within the past 12 weeks at registration. Exclusion Criteria: * Previous participation in this study. Participation is defined as having given informed consent in this study. * Treatment with any investigational drug within 30 days prior to baseline (the starting date of Alhemo treatment). * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * A history of hypersensitivity to any ingredients of Alhemo.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    23 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

  • Arin Clinic Shonika_Pediatrics

    Okinawa, 901-2132, Japan

  • Chiba university hospital_Pediatrics

    Chiba, 260-8677, Japan

  • Fukaya Red Cross Hospital_Haematology

    Saitama, 366-0052, Japan

  • Hamamatsu Medical Center_Pediatrics

    Shizuoka, 432-8580, Japan

  • Hoshi General Hospital_Pediatrics

    Fukushima, 963-8501, Japan

  • Hyogo Prefectural Amagasaki General Medical Center_Haematology

    Hyōgo, 660-8550, Japan

  • Ishiyama Clinic

    Yamagata, 992-0035, Japan

  • Iwata City Hospital_Haematology

    Shizuoka, 438-8550, Japan

  • Kansai Medical University Hospital_Pediatrics

    Osaka, 573-1191, Japan

  • Matsue red cross hospital_Pediatrics

    Shimane, 690-8506, Japan

  • Miyagi Children's Hospital_Hematology-Oncology

    Miyagi, 989-3126, Japan

  • Nagano Children's Hospital_Hematology-Oncology

    Nagano, 399-8288, Japan

  • Nagano red cross hospital_Pediatrics

    Nahano, 380-8582, Japan

  • Nanbu Medical Center & Children's Medical Center_Pediatric Hematology

    Okinawa, 901-1193, Japan

  • National Center for Child Health and Development_Hematology

    Tokyo, 157-8535, Japan

  • National Hospital Organization Awara Hospital_Hematology and Oncology

    Fukui, 910-4272, Japan

  • Ogikubo Hospital_Blood Coagulation

    Tokyo, 167-0035, Japan

  • Saitama Children's Med Centre_Hematology-Oncology

    Saitama, 330-8777, Japan

  • Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy

    Kawagoe, Japan

  • Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy

    Saitama, 350-8550, 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

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

    Okinawa, 901-2725, Japan