NCT00701545

Brief Summary

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®

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

First QC Date

June 18, 2008

Last Update Submit

February 10, 2011

Conditions

Von Willebrand Disease

Keywords

von Willebrand diseaseVWD, Humate-P®Infusion volume reducedivr

Outcome Measures

Primary Outcomes (1)

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

    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

    6 months

Study Arms (1)

1

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Toronto, Canada

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • David G. Barnes, Dr.

    CSL Behring Canada

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2008

First Posted

June 19, 2008

Study Start

February 1, 2008

Study Completion

April 1, 2009

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

CA(1)