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COMPLETED
NCT03875547

Post-marketing Surveillance (Use Result Surveillance) With Refixia®

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The participants are invited to take part in this study because they have Haemophilia B. The purpose of this study is to assess the safety and effectiveness of Refixia® about long-term routine use in patients with Haemophilia B. The participants will get Refixia® as prescribed to them by their study doctor. The study will last up to Sep 2025 for the participant. The participants may be asked to fill in the quality of life questionnaires (if they are above age of 15). The blood samples taken from the participants as part of routine clinical practice will also be used to investigate the safety for the long-term use of Refixia®.

Official title: Post-marketing Surveillance (Use Result Surveillance) With Refixia®. A Multicentre, Non-interventional Post Marketing Surveillance of Safety and Effectiveness of Refixia® in Routine Clinical Care With Haemophilia B Patients in Japan.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

28

Start Date

2019-08-23

Completion Date

2025-09-30

Last Updated

2026-04-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Refixia®

Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician

Locations (23)

Novo Nordisk Investigational Site

Søborg, Denmark

Nagoya University Hospital_Blood Transfusion

Aichi, Japan

Aomori Prefectural Central Hospital_Pediatrics

Aomori, Japan

Matsudo City General Hospital_Pediatrics

Chiba, Japan

Japan Red Cross Narita Hospital_Hematology and Oncology

Chiba, Japan

Chiba University Hospital_Diabetes, Metabolism and Endocrinology

Chiba-shi, Chiba, Japan

Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy

Hyōgo, Japan

Tokyo Medical University Ibaraki Medical Center_Ibaraki

Ibaraki, Japan

Ishikawa Prefectural Central Hospital_Haematology

Ishikawa, Japan

St. Marianna University School of Medicine Hospital_Pediatrics

Kanagawa, Japan

Kitasato University Hospital_Blood Transfusion

Kanagawa, Japan

Hospital of the University of Occupational And Environmental Health Japan_Pediatrics

Kitakyusyu-shi, Fukuoka, Japan

Gunma University Hospital_Hematology

Maebashi-shi, Gunma, Japan

Naha City Hospital_Cardiovascular Medicine

Naha-shi, Okinawa, Japan

Nara Medical University Hospital_Pediatrics

Nara, Japan

The Hospital of Hyogo College of Medicine_Haematology

Nishinomiya-shi, Hyogo, Japan

Saitama Children's Med Centre_Hematology-Oncology

Saitama, Japan

Tokushima University Hospital_Pediatrics

Tokushima, Japan

Tokushima Red Cross Hospital_Pediatrics

Tokushima, Japan

Tokyo Medical Univ. Hospital_Laboratory Medicine

Tokyo, Japan

Ogikubo Hospital_Blood Coagulation

Tokyo, Japan

Ishiyama Clinic

Yamagata, Japan

St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,

Yokohama-shi, Kanagawa, Japan