HYPATIA: A prospective randomised controlled trial of HYdroxychloroquine to improve Pregnancy outcome in women with AnTIphospholipid Antibodies

Guy's and St Thomas' NHS Foundation Trust0 个研究点目标入组 400 人开始时间: 2020年8月27日最近更新: 2023年11月13日

试验速览

2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28609801/ protocol (added 27/08/2020)

•1. 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.
•2. Written informed consent to participate

•1. Women who are already pregnant
•2. Allergy or adverse event to hydroxychloroquine. Hypersensitivity to the active substance, 4-aminoquinoline or any of the compounds of the IMP or placebo
•3. Current treatment with hydroxychloroquine
•4. Age < 18 and > 45
•5. Bodyweight < 45 kg
•6. Psoriasis
•7. Uncontrolled epilepsy
•8. Anti-Ro antibodies
•9. Renal replacement therapy
•10. Other severe active co-morbidities (HIV, hepatitis B, severe gastrointestinal, neurological or blood disorders)
•11. Porphyria
•12. History of retinopathy or newly diagnosed retinopathy
•13. History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption
•14. History of glucose-6-dehydrogenase deficiency
•15. Participation in any other IMP trial at the time of consent
•16. Previous pregnancy failure on hydroxychloroquine

发起方