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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00701545
First Posted: June 19, 2008
Last Update Posted: February 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CSL Behring
  Purpose

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®


Condition
Von Willebrand Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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®

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • To assess the safety and tolerability of Humate-P® (reported adverse events) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: February 2008
Study Completion Date: April 2009
Groups/Cohorts
1
Patients with von Willebrand disease treated with Humate P® ivr in Canada

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with von Willebrand disease treated with Humate P® ivr in Canada
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701545


Locations
Canada
Toronto, Canada
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: David G. Barnes, Dr. CSL Behring Canada
  More Information

Additional Information:
Responsible Party: Dr David G. Barnes, CSL Behring Canada, Inc.
ClinicalTrials.gov Identifier: NCT00701545     History of Changes
Other Study ID Numbers: CSLBC-HP-PM-001
First Submitted: June 18, 2008
First Posted: June 19, 2008
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by CSL Behring:
von Willebrand disease
VWD, Humate-P®
Infusion volume reduced
ivr

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn