NCT01613287已完成不适用
A Clinical Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Primary endpoint is the change of pulmonary vascular resistance (PVR) at rest before immunoadsorption compared to 3 months after immunoadsorption therapy determined by right heart catheterization (RHC).
研究概览
简要总结
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary Arterial Hypertension and WHO functional classification III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willing to sign the Informed Consent Form
- •age > 18 and < 80 years at time of informed consent
- •Idiopathic pulmonary arterial hypertension diagnosed by right heart catheter
- •WHO functional classification III
- •Application of conventional IPAH therapy, which has been stable for the prior 8 weeks
- •Able to perform a 6-minute-walk test (MWT)
- •Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the trial for women with child-bearing potential.
排除标准
- •Pregnancy and/or lactation
- •PAH of any cause other than permitted in the inclusion criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease
- •Contraindication for right heart catheterization
- •Any change in disease-targeted therapy within 8 weeks prior to inclusion
- •Walking impairment due to causes other than IPAH that would preclude performance of a 6MWT
- •Any patient who has received any investigational medication within 8 weeks prior to the start of this trial or who is scheduled to receive another investigational drug during the course of the trial between visits V1 and V9
- •Known intolerance to immunoadsorption in general or to one of the excipients (e.g. sheep antibodies or agarose) or other supporting agents
- •Hemoglobin concentration of < 75% below the lower limit of normal
- •Systolic blood pressure < 85 mmHg
- •Lack of compliance or other similar reason that, in the judgment of the Investigator, precludes satisfactory participation in the trial
- •Concurrent severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled generalized viral, bacterial and/ or mycotic infection) which by assessment of the treating Investigator could compromise patients safety or participation in the study
- •Drug or alcohol abuse within the last 5 years
- •Hypercoagulability
- •Known severe immunodeficiency (e.g. AIDS)
- •Severe lung disease: FEV1/FVC < 50%, total capacity < 60% of normal value
- •Indications that prohibit transient anticoagulation using Heparin and/or ACD-A-solutions
结局指标
主要结局
Primary endpoint is the change of pulmonary vascular resistance (PVR) at rest before immunoadsorption compared to 3 months after immunoadsorption therapy determined by right heart catheterization (RHC).
时间窗: Baseline, 3 months after therapy
次要结局
- all-cause mortality(~6months)
- occurrence and number of Adverse Events(~6 months)
- WHO functional classification(Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy)
- Six-minute walk test (6MWT)(Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy)
- Quality of life questionnaires(Measurements at baseline, and after ~1 month, ~3 months, ~6 months)
- Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP(Measurements at baseline, after ~3 months)
- Reduction of IgG(Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment)
研究者
研究点 (8)
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