Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

• Status: Terminated
• Trial end date: 2015-09-30
• Target enrollment: 0
• Participant gender: All

Summary

In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborators: AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking; APS ACTION; NY Community Trust Fund; The New York Community Trust
• Treatments: Antibodies, Antiphospholipid; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:

• aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or

• aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or

• Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations

Selected Exclusion Criteria:

• History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis

• History of Transient Ischemic Attack Confirmed by a Neurologist

• SLE Diagnosis based on the ACR Classification Criteria > 4/11

• Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria

• Current Hydroxychloroquine or another antimalarial treatment (-3 months)

• Current warfarin treatment (-3 months)

• Current heparin therapy( -3 months)

• Current pregnancy

• History of Hydroxychloroquine eye toxicity

• History of Hydroxychloroquine allergy

• Known glucose-6-phosphate dehydrogenase deficiency