Haemophilia A, Haemophilia BNCT06831734
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
An observational study of Haemophilia A, Haemophilia B, run by Novo Nordisk A/S at 23 sites in Japan.
Trial summary
The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years. Participants enrolment will be completed in the first 4 years. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Haemophilia A, Haemophilia B
- What is being tested?
- Concizumab
- How many people
- 30 participants
- Where
- 23 sitesJapan
- Study dates
- 2 May 2025to 31 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
Japan23 sites
Chiba university hospital_Pediatrics
Chiba, 260-8677
National Hospital Organization Awara Hospital_Hematology and Oncology
Fukui, 910-4272
Hoshi General Hospital_Pediatrics
Fukushima, 963-8501
Hyogo Prefectural Amagasaki General Medical Center_Haematology
Hyōgo, 660-8550
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, 216-8511
Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy
Kawagoe
Miyagi Children's Hospital_Hematology-Oncology
Miyagi, 989-3126
Nagano Children's Hospital_Hematology-Oncology
Nagano, 399-8288
Nagano red cross hospital_Pediatrics
Nahano, 380-8582
Nanbu Medical Center & Children's Medical Center_Pediatric Hematology
Okinawa, 901-1193
Arin Clinic Shonika_Pediatrics
Okinawa, 901-2132
University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology
Okinawa, 901-2725
Kansai Medical University Hospital_Pediatrics
Osaka, 573-1191
Saitama Children's Med Centre_Hematology-Oncology
Saitama, 330-8777
Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy
Saitama, 350-8550
Fukaya Red Cross Hospital_Haematology
Saitama, 366-0052
Matsue red cross hospital_Pediatrics
Shimane, 690-8506
Hamamatsu Medical Center_Pediatrics
Shizuoka, 432-8580
Iwata City Hospital_Haematology
Shizuoka, 438-8550
National Center for Child Health and Development_Hematology
Tokyo, 157-8535
Ogikubo Hospital_Blood Coagulation
Tokyo, 167-0035
Ishiyama Clinic
Yamagata, 992-0035
St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,
Yokohama-shi, Kanagawa, 241-0811
About this study
Official title: Special Use-results Surveillance on Use of Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Treatment With Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors in Routine Clinical Practice Conditions in Japan
The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years. Participants enrolment will be completed in the first 4 years. The observation period of this study will last for about 2 years for each enrolled participant.
- Conditions
- Haemophilia A, Haemophilia B
- Being tested
- Concizumab
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcizumabDrug
Also called Alhemo
Participants will be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Alhemo is made at the physician's discretion before and independently from this study.
| Study group | Role | What they receive |
|---|---|---|
| Concizumab | 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. Receives: Drug: Concizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse reaction (AR)
Count of adverse reaction.
Measured: From baseline (week 0) to end of study (week 104)
Secondary outcomes (7)
Number of serious adverse reaction (SAR)
Count of serious adverse reaction.
Measured: From baseline (week 0) to end of study (week 104)
Number of serious adverse event (SAE)
Count of serious adverse event.
Measured: From baseline (week 0) to end of study (week 104)
Number of thromboembolic adverse event (AE)
Count of thromboembolic adverse event.
Measured: From baseline (week 0) to end of study (week 104)
Number of shock/anaphylaxis adverse event (AE)
Count of shock/anaphylaxis adverse event.
Measured: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic bleeding episodes
Count of treated spontaneous and traumatic bleeding episodes.
Measured: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic target joint bleeding episodes
Count of treated spontaneous and traumatic target joint bleeding episodes.
Measured: From baseline (week 0) to end of study (week 104)
Number of all treatment requiring bleeding episodes
Count of all treatment requiring bleeding episodes.
Measured: From baseline (week 0) to end of study (week 104)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start2 May 2025
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia A, Haemophilia BStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831734
- Sponsor's protocol ID
- NN7415-7690
- Other IDs
- U1111-1286-2960
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Use-results Surveillance on Use of Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Treatment With Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors in Routine Clinical Practice Conditions in Japan
- ClinicalTrials.gov ID
- NCT06831734
- Acronym / sponsor ID
- NN7415-7690
- Conditions
- Haemophilia A, Haemophilia B
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 May 2025 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years. Participants enrolment will be completed in the first 4 years. The observation period of this study will last for about 2 years for each enrolled participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concizumab | – | Drug: ConcizumabParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConcizumabAlso: AlhemoParticipants will be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Alhemo is made at the physician's discretion before and independently from this study. | Drug | Concizumab |
Primary outcome
Number of adverse reaction (AR)
Time frame: From baseline (week 0) to end of study (week 104)
Count of adverse reaction.
7 secondary outcomes
Number of serious adverse reaction (SAR)
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse event (SAE)
Time frame: From baseline (week 0) to end of study (week 104)
Number of thromboembolic adverse event (AE)
Time frame: From baseline (week 0) to end of study (week 104)
Number of shock/anaphylaxis adverse event (AE)
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic bleeding episodes
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic target joint bleeding episodes
Time frame: From baseline (week 0) to end of study (week 104)
Number of all treatment requiring bleeding episodes
Time frame: From baseline (week 0) to end of study (week 104)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Related trials for Haemophilia A, Haemophilia B
Active, not recruitingPhase 3
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
Haemophilia A (Moderate or Severe)
Enrolling by invitationObservational study
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
Haemophilia B
Enrolling by invitationObservational study
Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Haemophilia A
RecruitingObservational study
Determinants and Consequences of the Transition to Adulthood for Adolescents With Severe Haemophilia: TRANSHEMO 2, an Ancillary Study to the TRANSHEMO Project
Haemophilia
Enrolling by invitationObservational study
Patient Preferences in Treatment of Haemophilia A With and Without Inhibitors: a Discrete Choice Experiment in Germany
Haemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A, Haemophilia B, run by Novo Nordisk A/S at 23 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse reaction (AR) (time frame: From baseline (week 0) to end of study (week 104)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.