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HYPATIA: A prospective randomised controlled trial of HYdroxychloroquine to improve Pregnancy outcome in women with AnTIphospholipid Antibodies
EU CTIS ID: 2023-504661-23-00
What this study is testing
To study the effect of HCQ on pregnancy outcome in women with antiphospholipid antibodies.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women with known aPL (i.e. isolated aPL or APS) who are planning pregnancy. aPL are defined by the presence of a positive test for anticardiolipin antibodies (IgG/IgM isotypes > 95th percentile) and/or lupus anticoagulant and/or anti- beta 2 glycoprotein-I (IgG/IgM isotypes > 95th percentile), on two or more consecutive occasions more than 12 weeks apart (a positive aPL test is defined under ‘glossary and definitions’). The last positive test must be within 12 months of study entry.
- Written informed consent to participate
You likely can't join if
- Women who are already pregnant
- Current treatment with hydroxychloroquine
- Age < 18 years and > 45 years
- Body weight < 45 kg
- Psoriasis
- Uncontrolled epilepsy
See the full eligibility criteria
- Women with known aPL (i.e. isolated aPL or APS) who are planning pregnancy. aPL are defined by the presence of a positive test for anticardiolipin antibodies (IgG/IgM isotypes > 95th percentile) and/or lupus anticoagulant and/or anti- beta 2 glycoprotein-I (IgG/IgM isotypes > 95th percentile), on two or more consecutive occasions more than 12 weeks apart (a positive aPL test is defined under ‘glossary and definitions’). The last positive test must be within 12 months of study entry.
- Written informed consent to participate
- Women who are already pregnant
- Current treatment with hydroxychloroquine
- Age < 18 years and > 45 years
- Body weight < 45 kg
- Psoriasis
- Uncontrolled epilepsy
- Anti-Ro antibodies
- Renal replacement therapy
- Women taking QT prolonging medications at screening will be excluded if QT prologation is identified at baseline ECG
- Other severe active co-morbidities (including but not limited to HIV, hepatitis B, significant gastrointestinal, liver, cardiac, neurological,or hematological disorders or kidney disease with an eGFR below 30ml/min in which the treating physician would advise against pregnancy)
- Porphyria
- History of retinopathy or newly diagnosed retinopathy
- History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- History of glucose-6-dehydrogenase deficiency
- Participation in any other IMP trial at the time of consent
- Previous pregnancy failure on hydroxychloroquine
- Allergy or adverse event to hydroxychloroquine. Hypersensitivity to the active substance, 4- aminoquinoline or any of the compounds of the IMP or placebo.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.