Hemophilia ANCT02225483
Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function
An observational study of Hemophilia A, run by CancerCare Manitoba at 2 sites in Canada.
Trial summary
The is study will examine whether variation in clinical bleeding frequency and severity among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in laboratory measurements of platelet activity. Read more about this study
- Who is it for?
- Ages 3 to 20 years, men only
- Conditions the study is for
- Hemophilia A
- How many people
- 42 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2014to Dec 2016
- 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 3 to 20 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%
Who may be able to join
- documented circulating FVIII level of ≤1%
- age 3 - 20 years
- may be on primary or secondary prophylaxis
- granting of informed consent
Who cannot join
- measurable inhibitor level at the time of enrollment
- ingestion of aspirin/supplement known to influence platelet function within 14 days of blood sampling, or ibuprofen within 3 days
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
The is study will examine whether variation in clinical bleeding frequency and severity among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in laboratory measurements of platelet activity.
- Conditions
- Hemophilia A
- Medical subject headings
- Hemophilia A
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 |
|---|---|---|
| Hemophilia A | Boys with Factor VIII coagulant activity less than or equal to 1%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procoagulant platelet-derived microparticle formation
Measured: At time of enrollment
Platelet aggregation
Whole blood platelet aggregation responses
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225483
- Sponsor's protocol ID
- H2013:304
- Status last verified
- Jan 2016
- First submitted
- 25 Aug 2014
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function
- ClinicalTrials.gov ID
- NCT02225483
- Acronym / sponsor ID
- H2013:304
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Novo Nordisk A/S
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Aug 2014 (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 is study will examine whether variation in clinical bleeding frequency and severity among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in laboratory measurements of platelet activity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophilia A | – | –Boys with Factor VIII coagulant activity less than or equal to 1%. |
Who may qualify
- Ages
- 3 to 20 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%
Key inclusion criteria (4 listed)
- documented circulating FVIII level of ≤1%
- age 3 - 20 years
- may be on primary or secondary prophylaxis
- granting of informed consent
Key exclusion criteria (2 listed)
- measurable inhibitor level at the time of enrollment
- ingestion of aspirin/supplement known to influence platelet function within 14 days of blood sampling, or ibuprofen within 3 days
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
Procoagulant platelet-derived microparticle formation
Time frame: At time of enrollment
Platelet aggregation
Time frame: At time of enrollment
Whole blood platelet aggregation responses
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 3 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by CancerCare Manitoba at 2 sites 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 4 inclusion and 2 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Procoagulant platelet-derived microparticle formation (time frame: At time of enrollment). The study lists 2 primary outcomes in all. 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 3 Feb 2017.