Post-marketing Surveillance (Use Result Surveillance) With Refixia®
- Conditions
- Haemophilia B
- Registration Number
- NCT03875547
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Signed consent obtained before any study-related activities (study-related<br> activities are any procedure related to recording of data according to the<br> protocol).<br><br> - The decision to initiate treatment with commercially available Refixia® has been<br> made by the patient/Legally Acceptable Representative (LAR) and the treating<br> physician before and independently from the decision to include the patient in this<br> study. At each site of this study, all patients will be registered consecutively<br> from the first patient after the launch of Refixia® (consecutively registered<br> system).<br><br> - Diagnosis of haemophilia B in males or females, no age limitation. Patients younger<br> than 12 years old will continue to be registered for 3 years of recruitment period<br> regardless of the target number of patients.<br><br> - New patients who have not been previously exposed to Refixia®. Also patients<br> previously exposed to Refixia® in NN7999-3639, -3747, -3774, -3775 or -3895 clinical<br> trial can be enrolled in this study. The patients who have participated in NN7999<br> -3774 or -3895 clinical trial can be enrolled in this study as continuous cases<br> until 30-September-2024 (one year before planned end of study date).<br><br>Exclusion Criteria:<br><br> - Previous participation in this study. Participation is defined as having given<br> informed consent in this study<br><br> - Mental incapacity, unwillingness or language barriers precluding adequate<br> understanding or cooperation<br><br> - Known or suspected hypersensitivity to study product or related products.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Adverse Reactions (ARs)
- Secondary Outcome Measures
Name Time Method Number of Serious Adverse Events (SAEs);Number of Serious Adverse Reactions (SARs);Number of bleeding episodes as assessed by annualised bleeding rate (ABR);Number of treatment requiring bleeding episodes as assessed by ABR;Haemostatic response of Refixia® in treatment of bleeds;Haemostatic response of Refixia® in treatment of bleeds in perioperative management during surgical procedures