Status:
UNKNOWN
HYDROxychloroquine in Syndrome Primary AntiPhospholipid
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Antiphospholipid Syndrome in Pregnancy
Anticoagulants
Eligibility:
FEMALE
18-48 years
Phase:
PHASE2
Brief Summary
Antiphospholipid syndrome (APS) is defined by thrombosis or obstetric complication (≥ 3 spontaneous miscarriages or fetal death or prematurity \<34 weeks gestation-related amenorrhea (SA)) associated ...
Detailed Description
The consecutive patientes with APS will be recruited in different ways based on daily practice; Patients fulfilling all criteria may be randomized following receipt of written informed consent. The r...
Eligibility Criteria
Inclusion
- Age \>18 years
- Spontaneous consecutive pregnancy ongoing before the 14th week of gestation
- \-- SAPL obstetrics (modified Sapporo criteria = Sydney criteria) with fetal death ≥10 weeks of gestation without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity \<34SA with placental insufficiency (with or without thrombotic SAPL)
- Signed informed consent
Exclusion
- Other SAPL subgroups: early isolated miscarriages \<10 weeks
- Contraindication to hydroxychloroquine:
- retinopathy,
- hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients especially lactose
- Associated systemic lupus, associated Sjogren syndrome
- Treatment with hydroxychloroquine in progress
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Lack of Social Insurance
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 2 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04275778
Start Date
July 9 2021
End Date
October 2 2025
Last Update
March 2 2022
Active Locations (1)
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1
Hopital Saint Antoine
Paris, France, 75012