EUCTR2017-004866-86-FR
Active, not recruiting
Phase 1
Evaluation of the benefit of adjuvant treatment with hydroxychloroquine to usual medical care for uncomplicated term pregnancy in patients with primary obstetrical antiphospholipid syndrome: randomized, double-blind, placebo-controlled phase II study. HYDROSAPL study - HYDROSAP
ConditionsPrimary obstetrical antiphospholipid syndromeMedDRA version: 20.0Level: PTClassification code 10002817Term: Antiphospholipid syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsPlaquenil
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary obstetrical antiphospholipid syndrome
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Woman aged \= to 18 years
- •\- Obstetric SAPL (modified Sapporo criteria \= Sydney criteria) defined as fetal death \=10 weeks of amenorrhea without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity \<34SA related to placental insufficiency with or without thrombotic SAPL
- •\- Spontaneous pregnancy in progress before 14 SA
- •\- Ability to give informed, written, dated and signed consent prior to the commencement of any trial\-related procedure and to comply with protocol recommendations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 110
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Other SAPL subgroups: early isolated miscarriage \<10 SA
- •\- Minor patient
- •\- Not affiliated to a social security scheme
- •\- Contraindication to hydroxychloroquine
- •o retinopathies,
- •o hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication, including lactose
- •\- Systemic systemic lupus, associated Sjogren syndrome
- •\- Hydroxychloroquine treatment in progress
- •\- Patient under guardianship or curatorship
- •\- Patient deprived of liberty
Outcomes
Primary Outcomes
Not specified
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