Von Willebrand DiseaseNCT00701545
A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)
An observational study of Von Willebrand Disease, run by CSL Behring at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Von Willebrand Disease
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with von Willebrand disease treated with Humate P® ivr in Canada
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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®
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®
- Conditions
- Von Willebrand Disease
- Keywords
- von Willebrand disease, VWD, Humate-P®, Infusion volume reduced, ivr
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with von Willebrand disease treated with Humate P® ivr in Canada |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of Humate-P® (reported adverse events)
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startFeb 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David G. Barnes, Dr., Study director, CSL Behring Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701545
- Sponsor's protocol ID
- CSLBC-HP-PM-001
- Status last verified
- Feb 2011
- First submitted
- 18 Jun 2008
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT00701545
- Acronym / sponsor ID
- CSLBC-HP-PM-001
- Conditions
- Von Willebrand Disease
- Keywords
- von Willebrand disease, VWD, Humate-P®, Infusion volume reduced, ivr
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with von Willebrand disease treated with Humate P® ivr in Canada |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with von Willebrand disease treated with Humate P® ivr in Canada
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the safety and tolerability of Humate-P® (reported adverse events)
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
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Von Willebrand Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G. Barnes, Dr. study director
CSL Behring Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Disease, run by CSL Behring at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of Humate-P® (reported adverse events) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.