CompletedNot Applicable

Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis

Germany, United Kingdom21 participantsStarted 2016-09

Plain-language summary

This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Reduced criteria! Phase 0 Inclusion Criteria: * Age ≥18 and ≤45 years; * Male or female; * Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and practice two reliable methods of contraception throughout the study. Exclusion Criteria: * Dysfunction of cerebral nervous system and/or heart disease; * History of preexisting chronic renal disease; * Treatment with ACE inhibitors; * Therapeutic full anticoagulation therapy prior to trial entry; * Liver abnormalities; * Clinically significant pulmonary edema and/or thrombocytopenia and/or anemia; * Active hepatitis B, C, or tuberculosis infection or HIV infection * Hypersensitivity to heparin and/or citrate; * Indications that prohibit transient anticoagulation using heparin and/or ACD-A-solutions; * Known intolerance to extracorporeal procedures in general or towards one of the individual excipients or towards other supporting agents; * Drug or alcohol abuse within the last 2 years; * Lack of compliance of subject; * History or diagnosis of severe periodontitis; Phase A and B Inclusion Criteria: * Age \>18 and ≤45 years ; * Pregnant woman with pre-term preeclampsia * sFlt-1/PlGF ratio ≥85 ; * sFlt-1 level of ≥ 8000pg/mL Exclusion Criteria: Maternal exclusion criteria * History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease; * History of preexisting chronic renal disease (CKD stage \>3a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)

Timeframe: until 2 weeks post treatment

Occurrence of AEs and SAEs in pregnant subjects and the fetus or infant until the 6 weeks post-delivery visit is reached (Phase A-B).

Timeframe: until 6 weeks post delivery

Trial details

NCT IDNCT02923206

SponsorMiltenyi Biomedicine GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-20

View on ClinicalTrials.gov More Preeclampsia trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.