NCT06464159 New Therapeutic Strategy Against Preeclampsia
| NCT ID | NCT06464159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-02-10 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Preeclampsia is a hypertensive disorder of pregnancy associated with important maternal and perinatal mortality. It complicates 2 to 5% of pregnancies and causes more than 70 000 maternal deaths each year worldwide. Although symptomatic management has improved there is currently no curative treatment, and only childbirth and delivery of the placenta, usually prematurely, alleviate the mother's symptoms. The management of extremely preterm infants is a major societal challenge in medical, ethical and economic terms. Placental insufficiency plays a central role in the pathophysiology of preeclampsia. Abnormal placentation during the first trimester leads to placental hypoperfusion, which induces trophoblast dysfunction and the release in maternal circulation of trophoblastic factors leading to the maternal symptoms. Among molecules that participate to the pathophysiology of preeclampsia, one of the most important players is soluble fms-like tyrosine kinase 1 (sFlt-1), which is a soluble form of the vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF) receptor. sFlt-1 binds to free VEGF and PlGF in the maternal circulation, thus reducing their bioavailability for their membrane receptors. Targeting the sFlt-1 pathway is one of the most promising strategies for the development of new treatments for preeclampsia. As sFlt-1 results from alternative splicing, its peptide sequence is identical to that of the extracellular part of the membrane receptor. The development of drugs that act specifically on the soluble form and not on the membrane form is therefore particularly complex. The general objective of this research is to restore the angiogenic balance that maintains the physiological concentrations of free angiogenic factors in order to significantly prolong the pregnancy and diminish the consequences of the great prematurity. The precise objectives of the APHERESE 2 project are: 1. To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column 2. To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient
Eligibility Criteria
Inclusion Criteria: * Age from 18 to 50 years old * Singleton pregnancies between 20 and 41 weeks of gestation * Preeclampsia / normal pregnancy Exclusion Criteria: * Age \< 18 years old * Infectious disease: HIV, HBV or HCV * Multiple pregnancies * refusal to participate in the protocol * Lack of social security cover
Contact & Investigator
Vassilis TSASARIS, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06464159 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06464159 currently recruiting?
Yes, NCT06464159 is actively recruiting participants. Contact the research team at vassilis.tsasaris@aphp.fr for enrollment information.
Where is the NCT06464159 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06464159 clinical trial?
NCT06464159 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Vassilis TSASARIS, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.