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

NCT06831734 | Enrolling By Invitation

• 2 other identifiers: NN7415-7690U1111-1286-2960
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Haemophilia A, Haemophilia B

Outcome Measures

Primary Outcomes (1)

• Number of adverse reaction (AR)

  Count of adverse reaction.

  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 adverse event (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 without inhibitors will be be treated with commercially available Alhemo according to routine clinical practice at the discretion of the treating physician.

Drug: Concizumab

Interventions

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.

Also known as: Alhemo

Concizumab

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• 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 without inhibitors will be be treated with commercially available Alhemo 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (9)

Chiba university hospital_Pediatrics

Chiba, 260-8677, Japan

Location

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, 216-8511, Japan

Location

Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy

Kawagoe, Japan

Location

Nagano red cross hospital_Pediatrics

Nahano, 380-8582, Japan

Location

Nanbu Medical Center & Children's Medical Center

Okinawa, 901-1193, Japan

Location

Kansai Medical University Hospital_Pediatrics

Osaka, 573-1191, Japan

Location

Saitama Medical Univ. Hospital Saitama medical center_Department of Transfusion Medicine and Cell Therapy

Saitama, 350-8550, Japan

Location

Matsue red cross hospital_Pediatrics

Shimane, 690-8506, Japan

Location

National Center for Child Health and Development_Hematology

Tokyo, 157-8535, 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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2031
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

JP (9)