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History of Changes for Study: NCT02923206
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis (SAVE)
Latest version (submitted November 9, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 3, 2016 None (earliest Version on record)
2 January 23, 2017 Study Status, Eligibility and Outcome Measures
3 April 10, 2017 Study Status
4 June 13, 2018 Contacts/Locations, Study Status and Eligibility
5 November 6, 2018 Contacts/Locations and Study Status
6 January 15, 2020 Study Status, Sponsor/Collaborators, Contacts/Locations and Eligibility
7 July 21, 2021 Contacts/Locations, Study Status and Sponsor/Collaborators
8 November 9, 2021 Contacts/Locations and Study Status
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Study NCT02923206
Submitted Date:  October 3, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: M-2016-313
Brief Title: Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis (SAVE)
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Recruiting
Study Start: September 2016
Primary Completion: April 2019 [Anticipated]
Study Completion: January 2020 [Anticipated]
First Submitted: September 19, 2016
First Submitted that
Met QC Criteria:
October 3, 2016
First Posted: October 4, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 3, 2016
Last Update Posted: October 4, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Miltenyi Biomedicine GmbH
Responsible Party: Sponsor
Collaborators: Cromsource
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Preeclampsia
Keywords: apheresis
pregnancy
pre-eclampsia
PE
sFlt-1
Pre-term
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 23 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Phase 0 - healthy volunteers
Phase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure.
Device: TheraSorb sFlt-1 adsorber
Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
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.
Device: TheraSorb sFlt-1 adsorber
Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
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.
Device: TheraSorb sFlt-1 adsorber
Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)
[ Time Frame: until 2 weeks post treatment ]

2. 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 ]

Secondary Outcome Measures:
1. Phase 0: Determine changes of sFlt-1 levels.
[ Time Frame: until 2 weeks post treatment ]

2. 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) ]

3. Phase 0: Concentration of antibody leaching during an apheresis procedure
[ Time Frame: During an apheresis procedure (1 day) ]

4. Phase 0: Change of HAMA levels in pre- and post apheresis blood
[ Time Frame: until 2 weeks post treatment ]

5. Phase 0: Evaluate blood pressure values
[ Time Frame: until 2 weeks post treatment ]

6. Phase 0: Evaluate spot urine values
[ Time Frame: until 2 weeks post treatment ]

7. Phase A/B: Occurrence of SAEs in the one year follow-up period
[ Time Frame: until end of FU, (1 year) ]

8. Phases A/B: Evaluate antibody leaching in phase A.
[ Time Frame: During the performance of the single apheresis treatment in Phase A (1 day) ]

9. Phases A and B: Evaluate maternal sFlt-1 levels.
[ Time Frame: Constant measures throughout the trial until delivery (up to 19 weeks) ]

10. Phases A/B: Evaluate the sFlt-1/PlGF ratio.
[ Time Frame: Constant measures throughout the trial until delivery (up to 19 weeks) ]

11. Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth.
[ Time Frame: at birth ]

12. Phases A/B: Determine HAMA levels
[ Time Frame: until 6 week FU visit ]

13. Phases A/B: Time and method of delivery, and anesthesia administered
[ Time Frame: at birth ]

14. Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization.
[ Time Frame: Following birth up to one year ]

15. Phases A/B: Evaluate standard markers of fetal development throughout pregnancy.
[ Time Frame: From start of trial until delivery (up to 19 weeks) ]

16. Phases A/B: Evaluate standard markers of neonatal development.
[ Time Frame: Directly following delivery until end of FU (1 year) ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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 and/ or preexisting clinically significant proteinuria, prior to pregnancy;
  • Treatment with ACE inhibitors/ renin-angiotensin-system blocker;
  • 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 infection;
  • 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;
  • Evidence of "reverse or zero Doppler" flow on umbilical Doppler;
  • Various Placental exclusion criteria;
  • Multiple pregnancy
  • History or diagnosis of severe periodontitis
  • Various fetal exclusion criteria
Open or close this module Contacts/Locations
Central Contact Person: Thomas F Hiemstra, MD
Telephone: +44 (0) 1223 336 817
Email: tfh24@cam.ac.uk
Study Officials: Thomas F Hiemstra, MD
Principal Investigator
Cambridge Clinical Trials Unit Addenbrooke's Hospital
Locations: United Kingdom
Cambridge Clinical Trials Unit, Addenbrooke's Hospital
[Recruiting]
Cambridge, United Kingdom, CB2 0QQ
Contact:Contact: Thomas F Hiemstra, MD +44 (0) 1223 336 817 tfh24@cam.ac.uk
Oxford Radcliffe Hospitals Nhs, John Radcliffe Hospital
[Not yet recruiting]
Oxford, United Kingdom, OX3 9DU
Contact:Contact: Lucy Mackillop, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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