HYDROxychloroquine in Syndrome Primary AntiPhospholipid
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 9 Jul 2021
- Ended
- 2 Oct 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Plaquenil 200Mg Tablet
- Placebo oral tablet
- Record updated
- 6 April 2026
- Why it stopped
- The study was terminated following revisions to the diagnostic criteria defining the target pathology, which significantly impacted the study design
Who can take part
- Age
- 18 years to 48 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Treatment with hydroxychloroquine in progress
- Contraindication to hydroxychloroquine:; retinopathy,; hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients especially lactose
- Associated systemic lupus, associated Sjogren syndrome
- Other SAPL subgroups: early isolated miscarriages <10 weeks
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Lack of Social Insurance
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 with antiphospholipid antibodies. The rate of term pregnancies has been improved by conventional treatment (aspirin 100 mg / day with low molecular weight heparin (LMWH) in an isocoagulant dose) to almost 75%. In the PROMISSE study, when considering progressive pregnancies after 20 weeks, 19% of pregnancies presented at least one complication despite the treatment (maternal, fetal or neonatal complications) related to APS. In the European APS register, maternal complications and IUGR were observed in 13% of cases, and prematurity in approximately 14% of cases despite treatment. In a previous study of 72 pregnancies during a LAS, we observed, under aspirin and LMWH, 25% of fetal losses, and 10% of at least one maternal and / or fetal complication or prematurity. The presence of lupus, a history of thrombosis, a circulating anticoagulant (ACC) and a triple positivity of antiphospholipids are considered to be factors associated with a poor obstetrical prognosis. Hydroxychloroquine (HCQ) has anti-inflammatory and anti-thrombotic properties. In vitro studies have shown that HCQ is able to restore the expression of placental annexin V, which has an anticoagulant effect and prevent the attachment of antiphospholipid antibodies to the placenta.
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HCQ during lupus decreases the thrombotic risk and its usefulness during thrombotic APS has been shown in a French series. In a European study, the addition of the HCQ to conventional treatment improved term pregnancies by 70% in the event of refractory APS. Its use during pregnancies of patients with lupus, the numerous data on tolerance during pregnancy and the follow-up of children born to mothers exposed to the HCQ demonstrates a reassuring tolerance profile for the mother and the fetus.
The objective of this clinical trial is to evaluate the benefit of addition or no of hydroxychloroquine to conventional treatment in obstetric APS.
The 2 groups in the trial
- HydroxychloroquineExisting treatment, for comparison
Hydroxychloroquine will be prescribed upon confirmation of pregancy at a dosage of 400 mg / day. Either in 2 doses (1 tablet of 200 mg in the morning and 1 tablet of 200 mg in the evening). Or in a single take: 2 tablets of 200 mg. Treatment will be continueted during the pregnancy and will be stopped at delivery.
Treatment: Plaquenil 200Mg Tablet
- Placebo groupPlacebo, for comparison
Placebo will be prescribed upon confirmation of pregancy at a dosage of 400 mg / day. Either in 2 doses (1 tablet of 200 mg in the morning and 1 tablet of 200 mg in the evening). Or in a single take: 2 tablets of 200 mg. Treatment will be continueted during the pregnancy and will be stopped at delivery.
Treatment: Placebo oral tablet
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the Benefit of Adjuvant Treatment With Hydroxychloroquine to the Usual Medical Management for Obtaining an Uncomplicated Term Pregnancy in Primary Obstetric Antiphospholipid Syndrome
- Record updated
- 6 April 2026