Preeclampsia
Conditions
Keywords
apheresis, pregnancy, pre-eclampsia, PE, sFlt-1, Pre-term
Brief 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.
Interventions
DEVICETheraSorb sFlt-1 adsorber
Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
Sponsors
Cromsource
Miltenyi Biomedicine GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0) | 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). | until 6 weeks post delivery |
Secondary
| Measure | Time frame |
|---|---|
| Phase 0: Concentration of antibody leaching during an apheresis procedure | During an apheresis procedure (1 day) |
| Phase 0: Change of HAMA levels in pre- and post apheresis blood | until 2 weeks post treatment |
| Phase 0: Evaluate blood pressure values | until 2 weeks post treatment |
| Phase 0: Evaluate spot urine values | until 2 weeks post treatment |
| Phase A/B: Occurrence of SAEs in the one year follow-up period | until end of FU, (1 year) |
| Phases A/B: Evaluate antibody leaching in phase A. | During the performance of the single apheresis treatment in Phase A (1 day) as well as pre and 3hrs post apheresis |
| Phases A and B: Evaluate maternal sFlt-1 levels. | Constant measures throughout the trial until delivery (up to 19 weeks) |
| Phase 0: Determine changes of sFlt-1 levels. | until 2 weeks post treatment |
| Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth. | at birth |
| Phases A/B: Determine HAMA levels | until 6 week FU visit |
| Phases A/B: Time and method of delivery, and anesthesia administered | at birth |
| Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization. | Following birth up to one year |
| Phases A/B: Evaluate standard markers of fetal development throughout pregnancy. | From start of trial until delivery (up to 19 weeks) |
| Phases A/B: Evaluate standard markers of neonatal development. | Directly following delivery until end of FU (1 year) |
| Phases A/B: Evaluate the sFlt-1/PlGF ratio. | Constant measures throughout the trial until delivery (up to 19 weeks) |
| Phase 0: Complement activation levels pre-, during and post apheresis. | Before, during and directly following the performance of the single apheresis treatment (1 day) |
Countries
Germany, United Kingdom
Outcome results
None listed