September 19, 2016
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October 4, 2016
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November 10, 2021
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September 2016
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February 2022 (Final data collection date for primary outcome measure)
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- Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0) [ Time Frame: 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). [ Time Frame: until 6 weeks post delivery ]
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Same as current
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- Phase 0: Determine changes of sFlt-1 levels. [ Time Frame: until 2 weeks post treatment ]
- Phase 0: Complement activation levels pre-, during and post apheresis. [ Time Frame: Before, during and directly following the performance of the single apheresis treatment (1 day) ]
- Phase 0: Concentration of antibody leaching during an apheresis procedure [ Time Frame: During an apheresis procedure (1 day) ]
- Phase 0: Change of HAMA levels in pre- and post apheresis blood [ Time Frame: until 2 weeks post treatment ]
- Phase 0: Evaluate blood pressure values [ Time Frame: until 2 weeks post treatment ]
- Phase 0: Evaluate spot urine values [ Time Frame: until 2 weeks post treatment ]
- Phase A/B: Occurrence of SAEs in the one year follow-up period [ Time Frame: until end of FU, (1 year) ]
- Phases A/B: Evaluate antibody leaching in phase A. [ Time Frame: 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. [ Time Frame: Constant measures throughout the trial until delivery (up to 19 weeks) ]
- Phases A/B: Evaluate the sFlt-1/PlGF ratio. [ Time Frame: Constant measures throughout the trial until delivery (up to 19 weeks) ]
- Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth. [ Time Frame: at birth ]
- Phases A/B: Determine HAMA levels [ Time Frame: until 6 week FU visit ]
- Phases A/B: Time and method of delivery, and anesthesia administered [ Time Frame: at birth ]
- Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization. [ Time Frame: Following birth up to one year ]
- Phases A/B: Evaluate standard markers of fetal development throughout pregnancy. [ Time Frame: From start of trial until delivery (up to 19 weeks) ]
- Phases A/B: Evaluate standard markers of neonatal development. [ Time Frame: Directly following delivery until end of FU (1 year) ]
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- Phase 0: Determine changes of sFlt-1 levels. [ Time Frame: until 2 weeks post treatment ]
- Phase 0: Complement activation levels pre-, during and post apheresis. [ Time Frame: Before, during and directly following the performance of the single apheresis treatment (1 day) ]
- Phase 0: Concentration of antibody leaching during an apheresis procedure [ Time Frame: During an apheresis procedure (1 day) ]
- Phase 0: Change of HAMA levels in pre- and post apheresis blood [ Time Frame: until 2 weeks post treatment ]
- Phase 0: Evaluate blood pressure values [ Time Frame: until 2 weeks post treatment ]
- Phase 0: Evaluate spot urine values [ Time Frame: until 2 weeks post treatment ]
- Phase A/B: Occurrence of SAEs in the one year follow-up period [ Time Frame: until end of FU, (1 year) ]
- Phases A/B: Evaluate antibody leaching in phase A. [ Time Frame: During the performance of the single apheresis treatment in Phase A (1 day) ]
- Phases A and B: Evaluate maternal sFlt-1 levels. [ Time Frame: Constant measures throughout the trial until delivery (up to 19 weeks) ]
- Phases A/B: Evaluate the sFlt-1/PlGF ratio. [ Time Frame: Constant measures throughout the trial until delivery (up to 19 weeks) ]
- Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth. [ Time Frame: at birth ]
- Phases A/B: Determine HAMA levels [ Time Frame: until 6 week FU visit ]
- Phases A/B: Time and method of delivery, and anesthesia administered [ Time Frame: at birth ]
- Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization. [ Time Frame: Following birth up to one year ]
- Phases A/B: Evaluate standard markers of fetal development throughout pregnancy. [ Time Frame: From start of trial until delivery (up to 19 weeks) ]
- Phases A/B: Evaluate standard markers of neonatal development. [ Time Frame: Directly following delivery until end of FU (1 year) ]
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Not Provided
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Not Provided
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Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
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Proof-of-Concept Trial on Selective Removal of the Antiangiogenic Factor Soluble Fms-like Tyrosine Kinase-1 (sFlt-1) in Pregnant Women With Preeclampsia Via Apheresis Utilizing the Flt-1 Adsorption Column
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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.
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Not Provided
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Interventional
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Not Applicable
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Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
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Preeclampsia
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Device: TheraSorb sFlt-1 adsorber
Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
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- Experimental: Phase 0 - healthy volunteers
Phase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure.
Intervention: Device: TheraSorb sFlt-1 adsorber
- Experimental: Phase A - preeclampsia patients
Phase A is a safety and dose-finding phase during which pregnant women diagnosed with preeclampsia will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure.
Intervention: Device: TheraSorb sFlt-1 adsorber
- Experimental: Phase B - preeclampsia patients
Phase B is a safety and efficacy phase during which pregnant women diagnosed with preeclampsia will undergo TheraSorb sFlt-1 adsorber apheresis procedures up to twice weekly.
Intervention: Device: TheraSorb sFlt-1 adsorber
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Not Provided
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Recruiting
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23
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Same as current
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February 2023
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February 2022 (Final data collection date for primary outcome measure)
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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, eGFR ≤45ml/min/1.73m²);
- Treatment with ACE inhibitors;
- Therapeutic full anticoagulation therapy prior to trial entry;
- Signs or history of clinically significant cerebral nervous system dysfunction;
- History of clinically significant liver abnormalities;
- Clinically significant pulmonary edema and/or thrombocytopenia and/or anemia;
- Active hepatitis B, C, tuberculosis infection or HIV-positive status;
- Any condition that the investigator deems a risk to the patient or fetus in completing the trial;
- Indications that prohibit transient anticoagulation using heparin and/or ACD-A-solutions;
- Drug or alcohol abuse within the last 2 years;
- Lack of compliance of patient;
- Known intolerance to extracorporeal procedures in general or to one of the excipients or other supporting agents;
- Hypersensitivity to heparin and/or citrate;
- < 30 0/7 weeks of gestation and abnormal CTG and/or abnormal Ductus venosus Doppler flow,
- ≥30 0/7 weeks of gestation and Doppler evidence of umbilical artery Absent or Reversed End-Diastolic Velocity (AREDV);
- Various Placental exclusion criteria;
- Multiple pregnancy
- History or diagnosis of severe periodontitis
Fetal exclusion criteria
- Any known trisomy;
- Amniotic fluid index <5cm (greatest single pocket <2cm);
- Estimated fetal weight <3rd percentile for gestational age;
- Fetus which are at high risk of heart disease;
- Fetus with congenital heart defect;
- Fetal signs of bleeding;
- Hydrops fetalis;
- Pathological fetal Doppler flow of the ductus venosus (absent A-wave in two measurements);
- Evidence of severe fetal malformations;
- Known infection of fetus;
- Known severe anemia.
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Sexes Eligible for Study: |
All |
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18 Years to 45 Years (Adult)
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Yes
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Germany, United Kingdom
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NCT02923206
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M-2016-313
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Yes
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Not Provided
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Miltenyi Biomedicine GmbH
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Same as current
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Miltenyi Biomedicine GmbH
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Same as current
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Cromsource
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Not Provided
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Miltenyi Biomedicine GmbH
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November 2021
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