Von Willebrand Disease
Conditions
Keywords
von Willebrand disease, VWD, Humate-P®, Infusion volume reduced, ivr
Brief summary
As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented. It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®
Interventions
None listed
Sponsors
CSL Behring
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male or female patients of any age; * Patients who are suffering with von Willebrand disease previously treated with Humate-P®; * Patients who are able to communicate well with the Investigator and his/her representatives; * Patients who are able and agreeing to comply with all study requirements; * Patients who have provided written signed and dated informed consent prior to any study procedures being performed.
Exclusion criteria
* Patients who have received any investigational drug ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Humate-P® (reported adverse events) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes | 6 months |
Countries
Canada
Outcome results
None listed