Health Condition 1: Q80-Q89- Other congenital malformations
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Novo Nordisk India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. The decision to initiate treatment with commercially available catridecacog (NovoThirteen®) 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. 3. Male or female, all ages below or equal to 80 years at the time of signing informed consent. 4. Actual or planned exposure to catridecacog (NovoThirteen®) for congenital FXIII A-subunit deficiency patients.
Exclusion criteria
Exclusion criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Treatment with any investigational drug within 30 days prior to enrolment into the study. 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse drug reactionsTimepoint: From baseline (week 0) to end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| All Serious Adverse EventsTimepoint: From baseline (week 0) to end of study;All medical events of special interestTimepoint: From baseline (week 0) to end of study;All medication errorsTimepoint: From baseline (week 0) to end of study;Near medication errorsTimepoint: From baseline (week 0) to end of study;Number of bleeding events during long-term routine use of catridecacog (NovoThirteen®)Timepoint: From baseline (week 0) to end of study | — |
Countries
India
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Ltd.
Outcome results
None listed