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

February 10, 2011 updated by: CSL Behring

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®

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with von Willebrand disease treated with Humate P® ivr in Canada

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with von Willebrand disease treated with Humate P® ivr in Canada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of Humate-P® (reported adverse events)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

  • Study Director: David G. Barnes, Dr., CSL Behring Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSLBC-HP-PM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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