Haemophilia A, Haemophilia B
Conditions
Brief 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.
Interventions
DRUGConcizumab
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 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
Exclusion criteria
\- Previous participation in this study. Participation is defined as having given informed consent in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse reaction (AR) | From baseline (week 0) to end of study (week 104) | Measured as count of ARs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse reaction (SAR) | From baseline (week 0) to end of study (week 104) | Measured as count of SARs. |
| Number of serious adverse event (SAE) | From baseline (week 0) to end of study (week 104) | Measured as count of SAEs. |
| Number of thromboembolic adverse event (AE) | From baseline (week 0) to end of study (week 104) | Measured as count of thromboembolic AEs. |
| Number of shock/anaphylaxis AE | From baseline (week 0) to end of study (week 104) | Measured as count of shock/anaphylaxis AEs. |
| Number of treated spontaneous and traumatic bleeding episodes | From baseline (week 0) to end of study (week 104) | Measured as count of bleeding episodes. |
| Number of treated spontaneous and traumatic target joint bleeding episodes | From baseline (week 0) to end of study (week 104) | Measured as count of bleeding episodes. |
| Number of all treatment requiring bleeding episode | From baseline (week 0) to end of study (week 104) | Measured as count of bleeding episodes. |
Countries
Japan
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed