Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-08

Study Completion Date

2030-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Haemophilia A Haemophilia B

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Concizumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Alhemo

Eligibility Criteria

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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