A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)
Completed
- Conditions
- Von Willebrand Disease
- Registration Number
- NCT00701545
- Lead Sponsor
- CSL Behring
- 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®
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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.
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of Humate-P® (reported adverse events) 6 months
- Secondary Outcome Measures
Name Time Method To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes 6 months