New study tracks Alhemo's Real-World safety in hemophilia patients
NCT ID NCT06831734
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Haemophilia A, haemophilia B are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
23 sites. The list below names each one and where it is.
-
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.
-
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