Von Willebrand DiseasePhase 4NCT00168090
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
A Phase 4 study testing Blood coagulation Factor VIII and vWF, human in people with Von Willebrand Disease and Blood Coagulation Disorders, run by CSL Behring at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Von Willebrand Disease, Blood Coagulation Disorders, Blood Platelet Disorders
- What is being tested?
- Blood coagulation Factor VIII and vWF, human
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to May 2006
- Phase
- Phase 4
- 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
Who may be able to join
- Subjects of any age
- Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP
- Require substitution with vWF/FVIII complex due to a surgery
Who cannot join
- Known significant hemostatic disorder other than vWD
- Acquired vWD
- Known antibodies to FVIII or vWF
- Known platelet type vWD
- Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol
- History of allergic reaction to Humate-P®
Show all 11Show fewer
- Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents)
- Progressive fatal disease/life expectancy of less than 6 months
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment
- Pediatric patients of insufficient body weight to permit PK sampling
- Woman in the first 20 weeks of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.
- Conditions
- Von Willebrand Disease, Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Disease
- Being tested
- Blood coagulation Factor VIII and vWF, human
- Keywords
- von Willebrand Factor, Blood Coagulation Disorders, Factor VIII
- Medical subject headings
- von Willebrand Diseases, Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Diseases, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood coagulation Factor VIII and vWF, humanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.
Secondary outcomes (1)
To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2001
- Study completionMay 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marylin J. Manco-Johnson, M.D., Principal investigator, Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168090
- Sponsor's protocol ID
- AP7000/1-4002
- Status last verified
- Feb 2011
- First submitted
- 12 Sep 2005
- Last updated
- 11 Feb 2011
- Results posted
- 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
- Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.
- ClinicalTrials.gov ID
- NCT00168090
- Acronym / sponsor ID
- AP7000/1-4002
- Conditions
- Von Willebrand Disease, Blood Coagulation Disorders, Blood Platelet Disorders, Hematologic Disease
- Keywords
- von Willebrand Factor, Blood Coagulation Disorders, Factor VIII
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- May 2006
- First posted
- 14 Sep 2005 (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.
The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects of any age
- Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP
- Require substitution with vWF/FVIII complex due to a surgery
Key exclusion criteria (11 listed)
- Known significant hemostatic disorder other than vWD
- Acquired vWD
- Known antibodies to FVIII or vWF
- Known platelet type vWD
- Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood coagulation Factor VIII and vWF, human | Drug | – |
Primary outcome
To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.
1 secondary outcome
To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.
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.
- Click here for more information about this study.Link provided by the sponsor.
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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.
Marylin J. Manco-Johnson, M.D. principal investigator
Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood coagulation Factor VIII and vWF, human in people with Von Willebrand Disease and Blood Coagulation Disorders, run by CSL Behring at 1 site in United States.
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 3 inclusion and 11 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.. 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.