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Hydroxychloroquine for Primary Thrombosis Prophylaxis in aPL Positive Patients
NCT01784523Phase 3
Key facts
- Status
- Terminated
- Start
- Feb 2013
- Primary completion
- Sep 2015
- Countries
- 1
- Sponsor
- Hospital for Special Surgery
- Modality
- Small Molecules
- Drugs
- hydroxychloroquine
- Conditions
- antiphospholipid syndrome (APS)
01
Overview
Phase 3, randomised, open-label trial of hydroxychloroquine in antiphospholipid syndrome (APS) (2 arms), sponsored by Hospital for Special Surgery. Primary endpoint: Number of Participants With an Acute Thrombosis Event at 2 years. Started Feb 2013; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard treatment
Standard of care (no additional treatment)
Hydroxychloroquine
Standard of care + Hydroxychloroquine
03
Who it enrols
Patients with persistent aPL-positivity (aCL, aβ2GPI, or LA) without history of thrombosis or systemic autoimmune diseases like SLE.
04
Endpoints
Primary
Number of Participants With an Acute Thrombosis Event
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