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OpenTrials
Completed

NCT Number: NCT00701545

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

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®

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Key information

Conditions

Von Willebrand Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To assess the safety and tolerability of Humate-P® (reported adverse events)

    Time frame: 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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®

Important dates

Study start
2008
Study completion
2009
First posted
Jun 19, 2008
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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