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

NCT ID: NCT02225483

Last Updated: 2017-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemophilia A

Boys with Factor VIII coagulant activity less than or equal to 1%.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

CancerCare Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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H2013:304

Identifier Type: -

Identifier Source: org_study_id

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