Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Aph… (NCT02923206) | Clinical Trial Compass
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 range18 Years – 45 Years
SexALL
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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…
What they're measuring
1
Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)
Timeframe: until 2 weeks post treatment
2
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).