Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
United Therapeutics
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may not be if
Eligible subjects:
Are between 18 and 75 years of age
Have a minimum weight of 45 kg
Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary cardiac shunt (at least one year since repair), or PAH associated with appetite suppressant/drug or toxin use confirmed by RHC
Have a current WHO functional class II or III designation
Have been stabilized, without dose changes for at least 30 days prior to the Screening visit on at least two approved PAH medications (e.g., PDE-5 inhibitor, ERA, prostanoid \[as inhalation or infusion\]); or IV prostanoid monotherapy. Subjects on an IV prostanoid must have been receiving therapy for at least three months prior to the Screening visit.
Have a 6MWD equal to or greater than 200 meters (m) at the Screening and Baseline Visits.
Subjects must not:
Have any evidence of pulmonary thrombus, significant coronary artery disease (CAD), left ventricular dysfunction, or a restrictive or congestive cardiomyopathy
Have a history of malignancies within the past 5 years,with the exception of individuals with localized, non-metastatic basal cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer who are not currently or expected to undergo radiation therapy, chemotherapy and/or surgical intervention, or to initiate hormonal treatment during the study
Be listed for transplantation
Be pregnant or nursing
Clareo Health | Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)