- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02225483
Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function
February 2, 2017 updated by: CancerCare Manitoba
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%
Description
Inclusion Criteria:
- documented circulating FVIII level of ≤1%
- age 3 - 20 years
- may be on primary or secondary prophylaxis
- granting of informed consent
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hemophilia A
Boys with Factor VIII coagulant activity less than or equal to 1%.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procoagulant platelet-derived microparticle formation
Time Frame: At time of enrollment
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At time of enrollment
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Platelet aggregation
Time Frame: At time of enrollment
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Whole blood platelet aggregation responses
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At time of enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 25, 2014
First Submitted That Met QC Criteria
August 25, 2014
First Posted (Estimate)
August 26, 2014
Study Record Updates
Last Update Posted (Estimate)
February 3, 2017
Last Update Submitted That Met QC Criteria
February 2, 2017
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2013:304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemophilia A
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Christoph KönigsRoche Pharma AG; Chugai Pharma Germany GmbHRecruitingSevere Hemophilia A | Severe Hemophilia A With Inhibitor | Severe Hemophilia A Without InhibitorGermany
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Kathelijn FischerRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingAdolescent | Child | Hemophilia A With Inhibitor | Adult | Hemophilia A Without Inhibitor | Hemophilia A, SevereNetherlands
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GWT-TUD GmbHHannover Medical School; Hoffmann-La RocheCompleted
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Hoffmann-La RocheActive, not recruitingSevere Hemophilia A | Moderate Hemophilia ABrazil, Germany, Italy, Spain, United States, Turkey, United Kingdom, Tunisia, Canada, Hungary, Ireland, Morocco, Serbia
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Catalyst BiosciencesCompletedHemophilia A | Hemophilia B | Hemophilia A With Inhibitor | Hemophilia B With Inhibitor | Hemophilia A Without Inhibitor | Hemophilia B Without InhibitorBulgaria, Russian Federation
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JW PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A Without InhibitorKorea, Republic of
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PfizerCompletedFactor VIII Deficiency, Congenital | Hemophilia A, Congenital | Factor 8 Deficiency, Congenital | Autosomal Hemophilia A | Classic Hemophilia
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BioMarin PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A With Anti Factor VIIIUnited States, United Kingdom, Taiwan, Korea, Republic of, Brazil, Italy
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American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
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BayerCompletedHemophilia A; Hemophilia BIsrael