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

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)

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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