Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-26 @ 11:09 AM
Study NCT ID:
NCT02923206
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2016-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2016-09-19', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)', 'timeFrame': 'until 2 weeks post treatment'}, {'measure': '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).', 'timeFrame': 'until 6 weeks post delivery'}], 'secondaryOutcomes': [{'measure': 'Phase 0: Determine changes of sFlt-1 levels.', 'timeFrame': 'until 2 weeks post treatment'}, {'measure': 'Phase 0: Complement activation levels pre-, during and post apheresis.', 'timeFrame': 'Before, during and directly following the performance of the single apheresis treatment (1 day)'}, {'measure': 'Phase 0: Concentration of antibody leaching during an apheresis procedure', 'timeFrame': 'During an apheresis procedure (1 day)'}, {'measure': 'Phase 0: Change of HAMA levels in pre- and post apheresis blood', 'timeFrame': 'until 2 weeks post treatment'}, {'measure': 'Phase 0: Evaluate blood pressure values', 'timeFrame': 'until 2 weeks post treatment'}, {'measure': 'Phase 0: Evaluate spot urine values', 'timeFrame': 'until 2 weeks post treatment'}, {'measure': 'Phase A/B: Occurrence of SAEs in the one year follow-up period', 'timeFrame': 'until end of FU, (1 year)'}, {'measure': 'Phases A/B: Evaluate antibody leaching in phase A.', 'timeFrame': 'During the performance of the single apheresis treatment in Phase A (1 day) as well as pre and 3hrs post apheresis'}, {'measure': 'Phases A and B: Evaluate maternal sFlt-1 levels.', 'timeFrame': 'Constant measures throughout the trial until delivery (up to 19 weeks)'}, {'measure': 'Phases A/B: Evaluate the sFlt-1/PlGF ratio.', 'timeFrame': 'Constant measures throughout the trial until delivery (up to 19 weeks)'}, {'measure': 'Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth.', 'timeFrame': 'at birth'}, {'measure': 'Phases A/B: Determine HAMA levels', 'timeFrame': 'until 6 week FU visit'}, {'measure': 'Phases A/B: Time and method of delivery, and anesthesia administered', 'timeFrame': 'at birth'}, {'measure': 'Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization.', 'timeFrame': 'Following birth up to one year'}, {'measure': 'Phases A/B: Evaluate standard markers of fetal development throughout pregnancy.', 'timeFrame': 'From start of trial until delivery (up to 19 weeks)'}, {'measure': 'Phases A/B: Evaluate standard markers of neonatal development.', 'timeFrame': 'Directly following delivery until end of FU (1 year)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apheresis', 'pregnancy', 'pre-eclampsia', 'PE', 'sFlt-1', 'Pre-term'], 'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Reduced criteria!\n\nPhase 0\n\nInclusion Criteria:\n\n* Age ≥18 and ≤45 years;\n* Male or female;\n* 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.\n\nExclusion Criteria:\n\n* Dysfunction of cerebral nervous system and/or heart disease;\n* History of preexisting chronic renal disease;\n* Treatment with ACE inhibitors;\n* Therapeutic full anticoagulation therapy prior to trial entry;\n* Liver abnormalities;\n* Clinically significant pulmonary edema and/or thrombocytopenia and/or anemia;\n* Active hepatitis B, C, or tuberculosis infection or HIV infection\n* Hypersensitivity to heparin and/or citrate;\n* Indications that prohibit transient anticoagulation using heparin and/or ACD-A-solutions;\n* Known intolerance to extracorporeal procedures in general or towards one of the individual excipients or towards other supporting agents;\n* Drug or alcohol abuse within the last 2 years;\n* Lack of compliance of subject;\n* History or diagnosis of severe periodontitis;\n\nPhase A and B\n\nInclusion Criteria:\n\n* Age \\>18 and ≤45 years ;\n* Pregnant woman with pre-term preeclampsia\n* sFlt-1/PlGF ratio ≥85 ;\n* sFlt-1 level of ≥ 8000pg/mL\n\nExclusion Criteria:\n\nMaternal exclusion criteria\n\n* History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease;\n* History of preexisting chronic renal disease (CKD stage \\>3a, eGFR ≤45ml/min/1.73m²);\n* Treatment with ACE inhibitors;\n* Therapeutic full anticoagulation therapy prior to trial entry;\n* Signs or history of clinically significant cerebral nervous system dysfunction;\n* History of clinically significant liver abnormalities;\n* Clinically significant pulmonary edema and/or thrombocytopenia and/or anemia;\n* Active hepatitis B, C, tuberculosis infection or HIV-positive status;\n* Any condition that the investigator deems a risk to the patient or fetus in completing the trial;\n* Indications that prohibit transient anticoagulation using heparin and/or ACD-A-solutions;\n* Drug or alcohol abuse within the last 2 years;\n* Lack of compliance of patient;\n* Known intolerance to extracorporeal procedures in general or to one of the excipients or other supporting agents;\n* Hypersensitivity to heparin and/or citrate;\n* \\< 30 0/7 weeks of gestation and abnormal CTG and/or abnormal Ductus venosus Doppler flow,\n* ≥30 0/7 weeks of gestation and Doppler evidence of umbilical artery Absent or Reversed End-Diastolic Velocity (AREDV);\n* Various Placental exclusion criteria;\n* Multiple pregnancy\n* History or diagnosis of severe periodontitis\n\nFetal exclusion criteria\n\n* Any known trisomy;\n* Amniotic fluid index \\<5cm (greatest single pocket \\<2cm);\n* Estimated fetal weight \\<3rd percentile for gestational age;\n* Fetus which are at high risk of heart disease;\n* Fetus with congenital heart defect;\n* Fetal signs of bleeding;\n* Hydrops fetalis;\n* Pathological fetal Doppler flow of the ductus venosus (absent A-wave in two measurements);\n* Evidence of severe fetal malformations;\n* Known infection of fetus;\n* Known severe anemia.'}, 'identificationModule': {'nctId': 'NCT02923206', 'acronym': 'SAVE', 'briefTitle': 'Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Miltenyi Biomedicine GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'M-2016-313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 0 - healthy volunteers', 'description': 'Phase 0 is an initial safety phase where subjects will undergo one single TheraSorb sFlt-1 adsorber apheresis procedure.', 'interventionNames': ['Device: TheraSorb sFlt-1 adsorber']}, {'type': 'EXPERIMENTAL', 'label': 'Phase A - preeclampsia patients', '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.', 'interventionNames': ['Device: TheraSorb sFlt-1 adsorber']}, {'type': 'EXPERIMENTAL', 'label': 'Phase B - preeclampsia patients', '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.', 'interventionNames': ['Device: TheraSorb sFlt-1 adsorber']}], 'interventions': [{'name': 'TheraSorb sFlt-1 adsorber', 'type': 'DEVICE', 'description': 'Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.', 'armGroupLabels': ['Phase 0 - healthy volunteers', 'Phase A - preeclampsia patients', 'Phase B - preeclampsia patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Cambridge Clinical Trials Unit, Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Thomas Benzing, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic Cologne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Miltenyi Biomedicine GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cromsource', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}