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

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00701545

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:	Case-Only, 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:

Genetics Home Reference related topics: hemophilia von Willebrand disease

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

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

No publications provided

Responsible Party:	CSL Behring Canada, Inc. ( Dr David G. Barnes )
Study ID Numbers:	CSLBC-HP-PM-001
Study First Received:	June 18, 2008
Last Updated:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00701545 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by CSL Behring:

von Willebrand disease
VWD, Humate-P®
Infusion volume reduced
ivr

Study placed in the following topic categories:

Von Willebrand Disease
Thrombocytopathy
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Platelet Disorders
Blood Coagulation Disorders
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:

Von Willebrand Disease
Coagulants
Hematologic Diseases
Coagulation Protein Disorders
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Agents

Factor VIII
Pharmacologic Actions
Blood Coagulation Disorders, Inherited
Hemorrhagic Disorders
Genetic Diseases, Inborn
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2009