Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Miltenyi Biotec B.V. & Co. KG
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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
You may not be if
Pregnancy and/or lactation
Clareo Health | Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension
