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

Von Willebrand Disease Clinical Trial

Official title:

A Canadian, Multi-center, Prospective, Open-label, Observational, Pharmacovigilance Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced) in Patients Transitioning From Treatment With Currently Available Humate-P®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701545
• Other study ID #: CSLBC-HP-PM-001
• Status: Completed
• Phase: N/A
• First received: June 18, 2008
• Last updated: February 10, 2011
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2011
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Von Willebrand Disease
• Von Willebrand Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of Humate-P® (reported adverse events)		6 months	Yes
Secondary	To capture efficacy data on Humate-P® ivr: • supporting clinical management of bleeding episode or surgery • incidence of relevant bleeding episodes		6 months	No

External Links

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