Haemophilia A, Haemophilia B
Conditions
Brief 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. The observation period of this study will last for about 2 years for each enrolled participant.
Interventions
DRUGConcizumab
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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse reaction (AR) | From baseline (week 0) to end of study (week 104) | Count of adverse reaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of serious adverse reaction (SAR) | From baseline (week 0) to end of study (week 104) | Count of serious adverse reaction. |
| Number of serious adverse event (SAE) | From baseline (week 0) to end of study (week 104) | Count of serious adverse event. |
| Number of thromboembolic adverse event (AE) | From baseline (week 0) to end of study (week 104) | Count of thromboembolic adverse event. |
| Number of shock/anaphylaxis adverse event (AE) | From baseline (week 0) to end of study (week 104) | Count of shock/anaphylaxis adverse event. |
| Number of treated spontaneous and traumatic bleeding episodes | From baseline (week 0) to end of study (week 104) | Count of treated spontaneous and traumatic bleeding episodes. |
| Number of treated spontaneous and traumatic target joint bleeding episodes | From baseline (week 0) to end of study (week 104) | Count of treated spontaneous and traumatic target joint bleeding episodes. |
| Number of all treatment requiring bleeding episodes | From baseline (week 0) to end of study (week 104) | Count of all treatment requiring bleeding episodes. |
Countries
Japan
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed