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

NCT06285071 | Enrolling By Invitation

• 2 other identifiers: NN7415-7557U1111-1274-4740
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Haemophilia A; Haemophilia B

Outcome Measures

Primary Outcomes (1)

• Number of adverse reaction (AR)

  Measured as count of ARs.

  From baseline (week 0) to end of study (week 104)

Secondary Outcomes (7)

• Number of serious adverse reaction (SAR)

  From baseline (week 0) to end of study (week 104)

• Number of serious adverse event (SAE)

  From baseline (week 0) to end of study (week 104)

• Number of thromboembolic adverse event (AE)

  From baseline (week 0) to end of study (week 104)

• Number of shock/anaphylaxis AE

  From baseline (week 0) to end of study (week 104)

• Number of treated spontaneous and traumatic bleeding episodes

  From baseline (week 0) to end of study (week 104)

Study Arms (1)

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.

Drug: Concizumab

Interventions

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.

Also known as: Alhemo

Concizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with haemophilia A or haemophilia B with inhibitors will be treated with commercially available concizumab according to routine clinical practice at the discretion of the treating physician.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (7)

Novo Nordisk Investigational Site

Toshima City, Tokyo, Japan

Location

Mutsu general hospital

Aomori, 035-8601, Japan

Location

Kyushu university hospital_Pediatrics

Fukuoka, 812-8582, Japan

Location

Sapporo Tokushukai Hospital_Pediatrics

Hokkaido, 004-0041, Japan

Location

Kagoshima City Hospital

Kagoshima, 890-8760, Japan

Location

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, 216-8511, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Interventions

concizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 29, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (7)