NCT02726139

Brief Summary

Commercial one and two-stage factor VIII assays may not detect some clinically significant inhibitor antibodies. The purpose of the proposed study is to standardize and validate a platelet-based factor VIII activity assay with greater sensitivity to clinically important inhibitory antibodies. Investigators will evaluate the platelet-dependent inhibitory activity vs. conventional inhibitory activity in stored patient plasmas and correlate to bleeding histories

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
Last Updated

February 25, 2021

Status Verified

March 1, 2016

Enrollment Period

4.5 years

First QC Date

March 29, 2016

Last Update Submit

February 23, 2021

Conditions

HemophiliaHemophilia A

Keywords

Factor VIIIinhibitorassay

Outcome Measures

Primary Outcomes (2)

  • Bleeding exceeds risk predicted by factor VIII assay

    annual bleeding rate exceeds the rate predicted from the residual factor VIII activity

    1 year

  • Bleeding is in accord with the risk assigned by platelet-dependent factor VIII activity

    annual bleeding rate is within the predicted range from residual factor VIII activity

    1 year

Study Arms (2)

Emory University

Samples obtained at and shipped from Emory University

University of Michigan

Samples obtained at and shipped from University of Michigan

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hemophilia A and inhibitory antibodies that have agreed to store plasma and prospectively consented to testing to evaluate bleeding mechanism

You may qualify if:

  • hemophilia A
  • presence of inhibitory antibodies

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston VA Research Institute (BVARI)

Boston, Massachusetts, 02130, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

frozen plasma

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

July 15, 2016

Primary Completion

January 25, 2021

Study Completion

January 25, 2021

Last Updated

February 25, 2021

Record last verified: 2016-03

Locations

US(1)