NCT00178607

Brief Summary

To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

13.2 years

First QC Date

September 12, 2005

Last Update Submit

May 10, 2016

Conditions

Hemophilia A

Keywords

Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Inactivation of antibodies by the FVIII covalent reactive analogs

    6 months

Eligibility Criteria

Age1 Day - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with Severe Hemophilia A and a positive inhibitor

You may qualify if:

  • Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher

You may not qualify if:

  • Severe Hemophilia A with a negative inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Univeristy of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and 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

Study Officials

  • Miguel Escobar, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Gulf States Hemophilia Center

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2002

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

The data will be analyzed and published

Locations

US(1)