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

Miltenyi Biotec logo

Miltenyi Biotec

Status

Enrolling

Conditions

Preeclampsia

Treatments

Device: TheraSorb sFlt-1 adsorber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02923206
M-2016-313

Details and patient eligibility

About

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.

Enrollment

23 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 3 patient groups

Phase 0 - healthy volunteers
Experimental group
Description:
Phase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure.
Treatment:
Device: TheraSorb sFlt-1 adsorber
Phase A - preeclampsia patients
Experimental group
Description:
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.
Treatment:
Device: TheraSorb sFlt-1 adsorber
Phase B - preeclampsia patients
Experimental group
Description:
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.
Treatment:
Device: TheraSorb sFlt-1 adsorber

Trial contacts and locations

4

Loading...

Central trial contact

Jörg Liebmann, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems