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

NCT02923206 | Completed DMC

• 1 other identifier: M-2016-313
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 4

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.

Conditions

Preeclampsia

Keywords

apheresis; pregnancy; pre-eclampsia; PE; sFlt-1; Pre-term

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Phase 0: Determine changes of sFlt-1 levels.

  until 2 weeks post treatment

• Phase 0: Complement activation levels pre-, during and post apheresis.

  Before, during and directly following the performance of the single apheresis treatment (1 day)

• 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

Study Arms (3)

Phase 0 - healthy volunteers

EXPERIMENTAL

Phase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure.

Device: TheraSorb sFlt-1 adsorber

Phase A - preeclampsia patients

EXPERIMENTAL

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.

Device: TheraSorb sFlt-1 adsorber

Phase B - preeclampsia patients

EXPERIMENTAL

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.

Device: TheraSorb sFlt-1 adsorber

Interventions

TheraSorb sFlt-1 adsorber DEVICE

Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.

Phase 0 - healthy volunteers; Phase A - preeclampsia patients; Phase B - preeclampsia patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Age \>18 and ≤45 years ;

Sponsors & Collaborators

• Miltenyi Biomedicine GmbH: lead
• Cromsource: collaborator

Study Sites (4)

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Cambridge Clinical Trials Unit, Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Thomas Benzing, Prof. Dr.

  University Clinic Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2016
• Primary Completion: August 20, 2024
• Study Completion: July 16, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); GB (2)