Haemophilia ANCT06285071
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
An observational study of Haemophilia A and Haemophilia B, run by Novo Nordisk A/S at 11 sites in Japan.
Trial summary
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Haemophilia A, Haemophilia B
- What is being tested?
- Concizumab
- How many people
- 23 participants
- Where
- 11 sitesJapan
- Study dates
- 8 Aug 2024to 30 Apr 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
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 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
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Japan11 sites
Mutsu general hospital_Pediatrics
Aomori, 035-8601
Kyushu university hospital_Pediatrics
Fukuoka, 812-8582
Sapporo Tokushukai Hospital_Pediatrics
Hokkaido, 004-0041
Kagoshima City Hospital_Pediatrics
Kagoshima, 890-8760
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, 216-8511
Hospital of the University of Occupational And Environmental Health Japan_Pediatrics
Kitakyusyu-shi, Fukuoka, 807 8555
Nanbu Medical Center & Children's Medical Center_Hematology and Oncology
Okinawa, 901-1193
University of the Ryukyus Hospital_Endocrinology and Metabolism, Hematology and Rheumatology
Okinawa, 901-2725
Tokyo Medical University Hospital
Tokyo, 160-0023
Ogikubo Hospital_Blood Coagulation
Tokyo, 167-0035
Novo Nordisk Investigational Site
Toshima City, Tokyo
About this study
Official title: A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.
- 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 (Concizumab) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Concizumab 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.
| Study group | Role | What they receive |
|---|---|---|
| Concizumab | Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. Recruitment will be completed after 4.5 years from the launch of Concizumab. The observation period for each participant is 2 years. Total duration of this study is about 6.5 years. 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)
Measured as count of ARs.
Measured: From baseline (week 0) to end of study (week 104)
Secondary outcomes (7)
Number of serious adverse reaction (SAR)
Measured as count of SARs.
Measured: From baseline (week 0) to end of study (week 104)
Number of serious adverse event (SAE)
Measured as count of SAEs.
Measured: From baseline (week 0) to end of study (week 104)
Number of thromboembolic adverse event (AE)
Measured as count of thromboembolic AEs.
Measured: From baseline (week 0) to end of study (week 104)
Number of shock/anaphylaxis AE
Measured as count of shock/anaphylaxis AEs.
Measured: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic bleeding episodes
Measured as count of bleeding episodes.
Measured: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic target joint bleeding episodes
Measured as count of bleeding episodes.
Measured: From baseline (week 0) to end of study (week 104)
Number of all treatment requiring bleeding episode
Measured as count of 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 posted29 Feb 2024
- Study start8 Aug 2024
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 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
- NCT06285071
- Sponsor's protocol ID
- NN7415-7557
- Other IDs
- U1111-1274-4740
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2024
- Last updated
- 15 Jun 2026
- Results posted
- 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
- A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan
- ClinicalTrials.gov ID
- NCT06285071
- Acronym / sponsor ID
- NN7415-7557
- Conditions
- Haemophilia A, Haemophilia B
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 29 Feb 2024 (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 all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concizumab | – | Drug: ConcizumabParticipants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available Alhemo (Concizumab) according to routine clinical practice at the discretion of the treating physician. Recruitment will be completed after 4.5 years from the launch of Concizumab. The observation period for each participant is 2 years. Total duration of this study is about 6.5 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 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 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
Key exclusion criteria (1 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
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 (Concizumab) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Concizumab 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. | Drug | Concizumab |
Primary outcome
Number of adverse reaction (AR)
Time frame: From baseline (week 0) to end of study (week 104)
Measured as count of ARs.
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 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 episode
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.
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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
11 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 and Haemophilia B, run by Novo Nordisk A/S at 11 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 4 inclusion and 1 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 11 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.