Status:
COMPLETED
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Hospital for Special Surgery, New York
Collaborating Sponsors:
Montefiore Medical Center
Conditions:
Antiphospholipid Syndrome
Thrombophilia Due to Antiphospholipid Antibody
Eligibility:
All Genders
18-65 years
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 hydroxychloroquin...
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 ...
Eligibility Criteria
Inclusion
- age 18 to 65
- new HCQ (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below)
- persistently positive aPL
- Selected
Exclusion
- Steroid use greater than or equal to the equivalent of prednisone 0.5 mg/kg/day at the time of enrollment
- Heparin use at the time of enrollment
- Any immunosuppressive drug use within 3 months prior to screening
- HCQ use within the past 6 months prior to screening visit
- Another antimalarial agent treatment,
- Pregnant women, minors, mentally disabled, prisoners
- Acute thrombosis within 2 weeks prior to screening
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01475149
Start Date
September 1 2010
End Date
August 1 2016
Last Update
March 27 2017
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021