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临床试验/NCT02923206
NCT02923206已完成不适用

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

Miltenyi Biomedicine GmbH4 个研究点 分布在 2 个国家目标入组 21 人开始时间: 2016年9月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
4
主要终点
Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Reduced criteria!
  • •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.

排除标准

  • •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;
  • 另有 2 项未显示

研究组 & 干预措施

Phase 0 - healthy volunteers

Experimental

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

干预措施: TheraSorb sFlt-1 adsorber (Device)

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.

干预措施: TheraSorb sFlt-1 adsorber (Device)

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.

干预措施: TheraSorb sFlt-1 adsorber (Device)

结局指标

主要结局

Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)

时间窗: 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).

时间窗: until 6 weeks post delivery

次要结局

  • Phase 0: Concentration of antibody leaching during an apheresis procedure(During an apheresis procedure (1 day))
  • Phases A/B:Evaluate neonatal umbilical cord blood sFlt-1 levels at birth.(at birth)
  • 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)
  • 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: Determine changes of sFlt-1 levels.(until 2 weeks post treatment)
  • Phase 0: Evaluate spot urine values(until 2 weeks post treatment)
  • Phase A/B: Occurrence of SAEs in the one year follow-up period(until end of FU, (1 year))
  • Phases A/B: Time and method of delivery, and anesthesia administered(at birth)
  • Phases A and B: Determine the post-partum maternal and neonatal length of hospitalization.(Following birth up to one year)
  • Phases A/B: Evaluate antibody leaching in phase A.(During the performance of the single apheresis treatment in Phase A (1 day) as well as pre and 3hrs post apheresis)
  • Phases A and B: Evaluate maternal sFlt-1 levels.(Constant measures throughout the trial until delivery (up to 19 weeks))
  • Phases A/B: Evaluate the sFlt-1/PlGF ratio.(Constant measures throughout the trial until delivery (up to 19 weeks))
  • Phases A/B: Evaluate standard markers of fetal development throughout pregnancy.(From start of trial until delivery (up to 19 weeks))
  • Phases A/B: Evaluate standard markers of neonatal development.(Directly following delivery until end of FU (1 year))
  • Phases A/B: Determine HAMA levels(until 6 week FU visit)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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