Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01475149
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2011-11-14
Brief Title:
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid aPL Positive Patients With and Without Systemic Lupus Erythematosus SLE
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine It will measure if these patients have a change in a blood test called the annexin A5 resistance assay over that 12 week period
Detailed Description:
Antiphospholipid Syndrome APS is an autoimmune disorder of blood clotting and pregnancy loss It is associated with proteins called antiphospholipid antibodies aPL in the blood Blood clotting in this disease occurs for several reasons one reason involves the interaction of aPL with another protein found on the surface of the cells that line blood vessels endothelial cells This protein called annexin A5 AnxA5 forms a shield over the surface of these cells The AnxA5 Resistance Assay is a blood test that can detect when there is a problem with the protective AnxA5 shield on endothelial cell surfaces
This 12 week study will observe patients with persistent aPL in the blood who are starting a medicine called hydroxychloroquine HCQ The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change Our secondary goal is to measure a variety of other blood tests before and after patients have started taking HCQ these tests include D-dimer Activated Protein C APC Resistance and aPL titersstatus LA test aCL ELISA aß2GPI ELISA and anti-Domain-I ß2GPI ELISA
This 12 week study will observe patients with persistent aPL in the blood who are starting a medicine called hydroxychloroquine HCQ The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change Our secondary goal is to measure a variety of other blood tests before and after patients have started taking HCQ these tests include D-dimer Activated Protein C APC Resistance and aPL titersstatus LA test aCL ELISA aß2GPI ELISA and anti-Domain-I ß2GPI ELISA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None