Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06831734

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-05-02

Completion Date

2031-01-31

Last Updated

2025-08-29

Healthy Volunteers

Not specified

Interventions

DRUG

Concizumab

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.

Locations (9)

Chiba university hospital_Pediatrics

Chiba, Japan

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, Japan

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

Kawagoe, Japan

Nagano red cross hospital_Pediatrics

Nahano, Japan

Nanbu Medical Center & Children's Medical Center

Okinawa, Japan

Kansai Medical University Hospital_Pediatrics

Osaka, Japan

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

Saitama, Japan

Matsue red cross hospital_Pediatrics

Shimane, Japan

National Center for Child Health and Development_Hematology

Tokyo, Japan