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NCT02225483 Clinical Trial

Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function

Hemophilia A Clinical Trial

Official title:
Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02225483
Other study ID # H2013:304
Secondary ID
Status Completed
Phase N/A
First received August 25, 2014
Last updated February 2, 2017
Start date September 2014
Est. completion date December 2016

Study information
Verified date January 2016
Source CancerCare Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date December 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Male
Age group 3 Years to 20 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada The Hospital for Sick Children Toronto Ontario
Canada CancerCare Manitoba Winnipeg Manitoba

Sponsors (3)
Lead Sponsor Collaborator
CancerCare Manitoba Novo Nordisk A/S, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procoagulant platelet-derived microparticle formation At time of enrollment
Primary Platelet aggregation Whole blood platelet aggregation responses At time of enrollment
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