PreeclampsiaAPHERESE2NCT06464159
New Therapeutic Strategy Against Preeclampsia
An observational study of Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Biological collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2026to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnancy with preeclampsia or intra uterine growth restriction (IUGR) and without preeclampsia and intra uterine growth restriction (IUGR) and complications
Who may be able to join
- Age from 18 to 50 years old
- Singleton pregnancies between 20 and 41 weeks of gestation
- Preeclampsia / normal pregnancy
Who cannot join
- Age < 18 years old
- Infectious disease: HIV, HBV or HCV
- Multiple pregnancies
- refusal to participate in the protocol
- Lack of social security cover
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Maternité Port-Royal
Paris, 75014
Vassilis TSASARIS, MD, PhD
About this study
Official title: New Therapeutic Strategy Against Preeclampsia : Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1 and Release of PlGF
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.
Read more
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:
- To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column
- To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient
Read the detailed description
The aim of this biobank is to setup a collection of maternal plasma and serum from patients with preeclampsia and patients with normal pregnancy. Assays of circulating angiogenic and anti-angiogenic factors (free and total forms) will be carried out on these serum and plasma at the hormonology laboratory in Cochin hospital (Paris, France) These results will make it possible to optimize and validate the development of extracorporeal sFlt-1 purification techniques.
Preeclampsia is a very heterogeneous disease in its clinical presentation, our hypothesis is that this heterogeneity corresponds to different profiles of angiogenic balance disturbance. Not all patients are likely to have the same expected benefit from extracorporeal clearance of sFlt-1. The objective is to assess the overall angiogenic balance on a large number of patients in order to determine which profile best corresponds to the indication for apheresis.
A prospective non-interventional study will be initiated to collect maternal blood samples during normal pregnancies and during pregnancies complicated by preeclampsia (Port-Royal Maternity, Cochin APHP). Blood samples will be collected after collection of written informed consent from 50 patients with preeclampsia and 50 patients without hypertensive disease.
- Between 20WG and 23WG+6D : 10 patients with PE and 10 patients with NP
- Between 24WG and 27WG+6D : 10 patients with PE and 10 patients with NP
- Between 28WG and 31WG+6D : 10 patients with PE and 10 patients with NP
- Between 32WG and 35WG+6D : 10 patients with PE and 10 patients with NP
- Between 36WG and 40WG+6D : 10 patients with PE and 10 patients with NP Inclusion of the patients will be performed through the Cochin maternal/neonatal investigation center.
- Conditions
- Preeclampsia
- Being tested
- Biological collection
- Keywords
- Preeclampsia, Apheresis, Angiogenic factors, Maternal biomarkers, sFLt-1, PIGF, Placenta, Pregnancy
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological collectionBiological
A collection of maternal plasma, serum and urine
| Study group | Role | What they receive |
|---|---|---|
| Preeclampsia | Pregnancy with preeclampsia Receives: Biological: Biological collection | |
| Pregnancies with intra uterine growth restriction (IUGR) | Pregnancy with intra uterine growth restriction (IUGR) Receives: Biological: Biological collection | |
| Normal pregnancy | Pregnancy without preeclampsia and intra uterine growth restriction (IUGR) and complications Receives: Biological: Biological collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of total sFlt-1
in pg/mL - to assess main angiogenic factors during PE, intra uterine growth restriction (IUGR) and normal pregnancy
Measured: 6 months
Concentration of free PlGF
in pg/mL - to assess main angiogenic factors during PE, intra uterine growth restriction (IUGR) and normal pregnancy
Measured: 6 months
Secondary outcomes (3)
Concentration of total PIGF
in pg/mL - to assess global circulating angiogenic balance during PE, intra uterine growth restriction (IUGR) and normal pregnancy
Measured: 6 months
Concentration of total VEGFA
in pg/mL - to assess global circulating angiogenic balance during PE, intra uterine growth restriction (IUGR) and normal pregnancy
Measured: 6 months
Concentration of total sVEGFR2
in pg/mL - to assess global circulating angiogenic balance, total VEGFA and total sVEGFR2 during PE, intra uterine growth restriction (IUGR) and normal pregnancy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start10 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Vassilis TSASARIS, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisEdouard LECARPENTIER, MD, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, FranceJean GUIBOURDENCHE, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464159
- Sponsor's protocol ID
- APHP231772
- Other IDs
- 2023-A01545-40
- Acronym
- APHERESE2
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic Strategy Against Preeclampsia : Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1 and Release of PlGF
- ClinicalTrials.gov ID
- NCT06464159
- Acronym / sponsor ID
- APHERESE2 / APHP231772
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Apheresis, Angiogenic factors, Maternal biomarkers, sFLt-1, PIGF, Placenta, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To transpose the proof of concept of the APHERESE1 project to the scale of a real apheresis column
- To develop an innovative assay technology to determine the global circulating angiogenic balance for each patient
Detailed description
The aim of this biobank is to setup a collection of maternal plasma and serum from patients with preeclampsia and patients with normal pregnancy. Assays of circulating angiogenic and anti-angiogenic factors (free and total forms) will be carried out on these serum and plasma at the hormonology laboratory in Cochin hospital (Paris, France) These results will make it possible to optimize and validate the development of extracorporeal sFlt-1 purification techniques.
Preeclampsia is a very heterogeneous disease in its clinical presentation, our hypothesis is that this heterogeneity corresponds to different profiles of angiogenic balance disturbance. Not all patients are likely to have the same expected benefit from extracorporeal clearance of sFlt-1. The objective is to assess the overall angiogenic balance on a large number of patients in order to determine which profile best corresponds to the indication for apheresis.
A prospective non-interventional study will be initiated to collect maternal blood samples during normal pregnancies and during pregnancies complicated by preeclampsia (Port-Royal Maternity, Cochin APHP). Blood samples will be collected after collection of written informed consent from 50 patients with preeclampsia and 50 patients without hypertensive disease.
- Between 20WG and 23WG+6D : 10 patients with PE and 10 patients with NP
- Between 24WG and 27WG+6D : 10 patients with PE and 10 patients with NP
- Between 28WG and 31WG+6D : 10 patients with PE and 10 patients with NP
- Between 32WG and 35WG+6D : 10 patients with PE and 10 patients with NP
- Between 36WG and 40WG+6D : 10 patients with PE and 10 patients with NP Inclusion of the patients will be performed through the Cochin maternal/neonatal investigation center.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preeclampsia | – | Biological: Biological collectionPregnancy with preeclampsia |
| Pregnancies with intra uterine growth restriction (IUGR) | – | Biological: Biological collectionPregnancy with intra uterine growth restriction (IUGR) |
| Normal pregnancy | – | Biological: Biological collectionPregnancy without preeclampsia and intra uterine growth restriction (IUGR) and complications |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnancy with preeclampsia or intra uterine growth restriction (IUGR) and without preeclampsia and intra uterine growth restriction (IUGR) and complications
Key inclusion criteria (3 listed)
- Age from 18 to 50 years old
- Singleton pregnancies between 20 and 41 weeks of gestation
- Preeclampsia / normal pregnancy
Key exclusion criteria (5 listed)
- Age < 18 years old
- Infectious disease: HIV, HBV or HCV
- Multiple pregnancies
- refusal to participate in the protocol
- Lack of social security cover
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological collectionA collection of maternal plasma, serum and urine | Biological | Normal pregnancy, Preeclampsia, Pregnancies with intra uterine growth restriction (IUGR) |
Primary outcome
Concentration of total sFlt-1
Time frame: 6 months
in pg/mL - to assess main angiogenic factors during PE, intra uterine growth restriction (IUGR) and normal pregnancy
Concentration of free PlGF
Time frame: 6 months
in pg/mL - to assess main angiogenic factors during PE, intra uterine growth restriction (IUGR) and normal pregnancy
3 secondary outcomes
Concentration of total PIGF
Time frame: 6 months
Concentration of total VEGFA
Time frame: 6 months
Concentration of total sVEGFR2
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vassilis TSASARIS, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Edouard LECARPENTIER, MD, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
Jean GUIBOURDENCHE, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vassilis TSASARIS, MD, PhD (+33 158413871, vassilis.tsasaris@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of total sFlt-1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.