Post-marketing Surveillance (Use Result Surveillance) With Refixia®
NCT ID: NCT03875547
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
20 participants
OBSERVATIONAL
2019-08-23
2025-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Following Males With Haemophilia B on Prophylaxis With Refixia/REBINYN
NCT03745924
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
NCT02922231
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors
NCT06312475
RIXUBIS Drug Use-Result Survey (Japan)
NCT02937831
Patient-reported Outcomes in Subjects Treated With ReFacto AF Routine Prophylaxis
NCT02718677
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with haemophilia B
Both patients who have not previously been exposed to Refixia® and patients previously exposed to Refixia® in one of the clinical trials can be included.
Refixia®
Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Refixia®
Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The decision to initiate treatment with commercially available Refixia® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. At each site of this study, all patients will be registered consecutively from the first patient after the launch of Refixia® (consecutively registered system).
* Diagnosis of haemophilia B in males or females, no age limitation. Patients younger than 12 years old will continue to be registered for 3 years of recruitment period regardless of the target number of patients.
* New patients who have not been previously exposed to Refixia®. Also patients previously exposed to Refixia® in NN7999-3639, -3747, -3774, -3775 or -3895 clinical trial can be enrolled in this study. The patients who have participated in NN7999 -3774 or -3895 clinical trial can be enrolled in this study as continuous cases until 30-September-2024 (one year before planned end of study date).
Exclusion Criteria
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Known or suspected hypersensitivity to study product or related products.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Hyōgo, , Japan
Tokyo Medical University Ibaraki Medical Center_Ibaraki
Ibaraki, , Japan
Ishikawa Prefectural Central Hospital
Ishikawa, , Japan
St. Marianna University School of Medicine Hospital_Pediatrics
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
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
Hospital of the University of Occupational And Environmental Health Japan, Pediatrics
Kitakyusyu-shi, Fukuoka, , Japan
Gunma University Hospital, Dept. of 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_Tokyo
Tokyo, , Japan
Ishiyama Clinic
Yamagata, , Japan
St. Marianna Univ., Yokohama City Seibu HP, Pediatrics Dept,
Yokohama-shi, Kanagawa, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1198-6270
Identifier Type: OTHER
Identifier Source: secondary_id
NN7999-4404
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.