Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Hospital for Special Surgery (HSS)

Status and phase: Terminated; Phase 3

Conditions: Antiphospholipid Syndrome

Treatments: Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01784523

2014-253

Details and patient eligibility

About

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.

Full description

Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.

This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.

Enrollment: 11 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Standard treatment

No Intervention group

Description:

patients randomized to standard treatment will not receive hydroxychloroquine.

Hydroxychloroquine

Experimental group

Description:

Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.

Treatment:

Drug: Hydroxychloroquine