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Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo
Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734

Enrolling By InvitationN/A

Sponsor: Novo Nordisk A/S

Conditions: Haemophilia A, Haemophilia B

Interventions: Concizumab

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (23)
  • Chiba, Japan
  • Fukui, Japan
  • Fukushima, Japan
  • Hyōgo, Japan
  • Kanagawa, Japan
  • Kawagoe, Japan
  • Miyagi, Japan
  • Nagano, Japan
  • Nahano, Japan
  • Okinawa, Japan
  • Okinawa, Japan
  • Okinawa, Japan
  • Osaka, Japan
  • Saitama, Japan
  • Saitama, Japan
  • Saitama, Japan
  • Shimane, Japan
  • Shizuoka, Japan
  • Shizuoka, Japan
  • Tokyo, Japan
  • Tokyo, Japan
  • Yamagata, Japan
  • Yokohama-shi, Kanagawa, Japan