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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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®

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)

NCT00168090

Von Willebrand Disease Blood Coagulation Disorders Blood Platelet Disorders +1 more

COMPLETED PHASE4

A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.

NCT02250508

vonWillebrand's Disease

COMPLETED PHASE2

Canadian Hemophilia Prophylaxis Study

NCT01085344

Severe Hemophilia A

COMPLETED PHASE4

A Study Assessing HMB-002 in Participants With Von Willebrand Disease

NCT06754852

Von Willebrand Disease (VWD) Von Willebrand Disease (VWD), Type 1 Von Willebrand Disease (VWD), Type 2

RECRUITING PHASE1/PHASE2

An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

NCT02427217

Congenital Fibrinogen Deficiency

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Von Willebrand Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No