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

CSL Behring

Status: Completed

Conditions: Von Willebrand Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00701545

CSLBC-HP-PM-001

Details and patient eligibility

About

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®

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

1

Description:

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