Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Hospital for Special Surgery (HSS) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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