An observational study in Haemophilia A and Haemophilia B, sponsored by Novo Nordisk A/S. Enrolling by invitation at 11 sites in Japan. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Novo Nordisk A/S · Observational
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's planned enrollment of 23 is below the median of 80 across 314 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
- Previous participation in this study. Participation is defined as having given informed consent in this study
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.
Drug: Concizumab
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.
Also known as: Alhemo
Number of adverse reaction (AR)
Measured as count of ARs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse reaction (SAR)
Measured as count of SARs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of serious adverse event (SAE)
Measured as count of SAEs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of thromboembolic adverse event (AE)
Measured as count of thromboembolic AEs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of shock/anaphylaxis AE
Measured as count of shock/anaphylaxis AEs.
Time frame: From baseline (week 0) to end of study (week 104)
Number of treated spontaneous and traumatic bleeding episodes
Measured as count of bleeding episodes.
Time frame: 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.
Time frame: From baseline (week 0) to end of study (week 104)
Number of all treatment requiring bleeding episode
Measured as count of bleeding episodes.
Time frame: From baseline (week 0) to end of study (week 104)
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Novo Nordisk A/S