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Enrolling by Invitation

NCT Number: NCT06285071

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

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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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Toshima City, Tokyo, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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 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

Exclusion criteria

  • Previous participation in this study. Participation is defined as having given informed consent in this study

Treatment and study plan

Concizumab

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.

Other names: Alhemo

Primary outcomes

  1. Number of adverse reaction (AR)

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

    Measured as count of ARs.

Secondary outcomes

  1. Number of serious adverse reaction (SAR)

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

    Measured as count of SARs.

  2. Number of serious adverse event (SAE)

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

    Measured as count of SAEs.

  3. Number of thromboembolic adverse event (AE)

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

    Measured as count of thromboembolic AEs.

  4. Number of shock/anaphylaxis AE

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

    Measured as count of shock/anaphylaxis AEs.

  5. Number of treated spontaneous and traumatic bleeding episodes

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

    Measured as count of 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)

    Measured as count of bleeding episodes.

  7. Number of all treatment requiring bleeding episode

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

    Measured as count of bleeding episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 29, 2024
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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