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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- Occurrence of AEs and SAEs in healthy volunteers until the 2 weeks follow-up (Phase 0)
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
- •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
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))
- 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: 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: 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 neonatal umbilical cord blood sFlt-1 levels at birth.(at birth)
- 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
研究点 (8)
Loading locations...
相似试验
进行中（未招募）
不适用
Targeted Microwave Tissue Coagulation for Prostate CancerProstate CancerNCT06430749Osamu Ukimura65
已完成
不适用
Drug-Eluting Balloon in Arteriovenous GraftAngioplastyDialysisKidney Failure, ChronicNCT03388892National Taiwan University Hospital Hsin-Chu Branch44
已完成
不适用
Evaluation of a Novel Product for the Removal of Impacted Human Cerumen (Earwax)Cerumen Impaction of Both EarsNCT02829294Dr. Joseph Griffin19
已完成
不适用
A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimer's Disease.Alzheimer Disease (AD)NCT06620640Neuromedical Sp. z o.o.105
终止
3 期
Minimally Invasive Surgical Therapy for BPHBenign Prostatic HyperplasiaNCT00064649National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)49