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

This study has been completed.
Sponsor:
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT00701545
First received: June 18, 2008
Last updated: February 10, 2011
Last verified: February 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701545

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

Additional Information:
Click here to request more information about this study  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: June 18, 2008
Last Updated: February 10, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013