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Enrolling by Invitation

NCT Number: NCT06831734

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

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.

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Key information

Conditions

Haemophilia A, Haemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chiba university hospital_Pediatrics, Chiba, Japan

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Concizumab

Drug

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.

Other names: Alhemo

Primary outcomes

  1. Number of adverse reaction (AR)

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of adverse reaction.

Secondary outcomes

  1. Number of serious adverse reaction (SAR)

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of serious adverse reaction.

  2. Number of serious adverse event (SAE)

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of serious adverse event.

  3. Number of thromboembolic adverse event (AE)

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of thromboembolic adverse event.

  4. Number of shock/anaphylaxis adverse event (AE)

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of shock/anaphylaxis adverse event.

  5. Number of treated spontaneous and traumatic bleeding episodes

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of treated spontaneous and traumatic bleeding episodes.

  6. Number of treated spontaneous and traumatic target joint bleeding episodes

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of treated spontaneous and traumatic target joint bleeding episodes.

  7. Number of all treatment requiring bleeding episodes

    Time frame: From baseline (week 0) to end of study (week 104)

    Count of all treatment requiring bleeding episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Special Use-results Surveillance on Use of Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Treatment With Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors in Routine Clinical Practice Conditions in Japan

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Feb 18, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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