Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo (NCT06831734) | Clinical Trial Compass
By InvitationNot Applicable
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
Japan30 participantsStarted 2025-05-02
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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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 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.
What they're measuring
1
Number of adverse reaction (AR)
Timeframe: From baseline (week 0) to end of study (week 104)