HYPATIA: A prospective randomised controlled trial of hydroxychloroquine to improve pregnancy outcome in women with antiphospholipid antibodies

Phase 3

• Conditions: Women with persistent antiphospholipid antibodies who are planning pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN19920789
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-27
• Last Update Posted: 13 November 2023
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified