A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)

CSL Behring21 enrolled

Overview

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®

Study Type

OBSERVATIONAL

Enrollment

Conditions

Von Willebrand Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Toronto, Canada

Outcomes

Primary Outcomes

To assess the safety and tolerability of Humate-P® (reported adverse events)

Time frame: 6 months

Secondary Outcomes

To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes

Time frame: 6 months

Data from ClinicalTrials.gov

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