Overview

Hydroxychloroquine for Thrombosis Prevention and Antiphospholipid Antibody Reduction in Primary Antiphospholipid Syndrome

Status:
Completed

Trial end date:
2019-10-16

Target enrollment:
0

Participant gender:
All

Summary

This is an interventional drug study designed as a pilot for a randomized clinical trial, aimed at assessing the effect of hydroxychloroquine on the incidence rate of thrombosis in patients with primary antiphospholipid syndrome as the main outcome, as well as the safety of hydroxychloroquine administration in this population. In addition, the effect of hydroxychloroquine on antiphospholipid antibody titers will be assessed.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National and Kapodistrian University of Athens

Treatments:

Antibodies
Antibodies, Antiphospholipid
Antimalarials
Hydroxychloroquine
Immunoglobulins

Criteria

Inclusion Criteria:

Adult patients diagnosed with primary antiphospholipid syndrome (PAPS) [updated Sapporo
criteria: Miyakis et al, J Thromb Haemost. 2006 Feb;4(2):295-306. PubMed 16420554]

Exclusion Criteria:

1. ≥4 American College of Rheumatology (ACR) classification criteria for Systemic Lupus
Erythematosus (SLE)

2. ACR classification criteria for other systemic autoimmune disorders

3. active malignancy

4. treatment with Hydroxychloroquine (HCQ) in the previous 12 months

5. history of serious adverse events or contraindication to HCQ including a history of
HCQ allergy, HCQ eye toxicity, or glucose-6-phosphate dehydrogenase deficiency,
uncontrolled seizure disorder, liver enzyme elevation >2-fold the upper normal limit,
and creatinine clearance <30ml/min