NCT00151385

Brief Summary

This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (\> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.

Trial Health

37
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2005

Geographic Reach
7 countries

23 active sites

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

First QC Date

September 6, 2005

Last Update Submit

June 26, 2012

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

  • Description of the patterns of antibodies and associated epitopes in a subset of

  • previously treated patients with hemophilia A.

Interventions

single blood drawPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • · Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime.

You may not qualify if:

  • Patients who have had an inhibitor prior to their current inhibitor.
  • Patients with immune disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

New Hyde Park, New York, 11040, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19134, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78207, United States

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

La Bouëxière, 35340, France

Location

Unknown Facility

Le Kremlin-Bicêtre, 94275, France

Location

Unknown Facility

Lyon, 69003, France

Location

Unknown Facility

Berlin, 10249, Germany

Location

Unknown Facility

Bonn, 53105, Germany

Location

Unknown Facility

Bremen, D-28205, Germany

Location

Unknown Facility

München, 81336, Germany

Location

Unknown Facility

Münster, 48103, Germany

Location

Unknown Facility

Florence, 50134, Italy

Location

Unknown Facility

Milan, 20122, Italy

Location

Unknown Facility

Madrid, 28046, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

London, E1 1BB, United Kingdom

Location

Unknown Facility

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trail Manager

    For Italy, decresg@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Spain, MedInfoNord@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For UK, ukmedinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Belgium, trials-BEL@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Germany, MedInfoDEU@wyeth.com

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

November 1, 2005

Study Completion

October 1, 2007

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

DE(5)FR(3)BE(2)IT(2)ES(2)GB(2)US(7)