Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
35–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Weight ≥ 40 kg at screening
Diagnosis of IPF based on modified American Thoracic Society-European Respiratory Society guidelines
Diagnosis of PH based on the following hemodynamic requirements: mean pulmonary artery pressure (mPAP ≥ 25 mm Hg; pulmonary vascular resistance \> 240 dyne.sec/cm\^5; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mm Hg
Forced vital capacity (FVC) ≥ 40%
Able to walk at least 50 meters during two 6-minute walk tests
If receiving calcium channel blockers, low-dose oral corticosteroids, immunosuppressive, cytoxic, or antifibrotic drugs dose must have been stable.
You may not be if
Diagnosis of PH primarily due to an etiology other than IPF
Surgical lung biopsy diagnosis other than Usual Interstitial Pneumonia
Other known cause of interstitial lung disease
Evidence of significant obstructive lung disease
Recent hospitalization for an acute exacerbation of IPF
Recent active pulmonary or upper respiratory tract infection
Left ventricular ejection fraction \< 40%
Serum creatinine ≥ 2.5 mg/dL
Required hemodialysis, peritoneal dialysis, or hemofiltration
Female subject who was pregnant or breastfeeding
Recent treatment for PH with an endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor, or prostacyclin derivative
Recent treatment with high dose oral corticosteroids
Recent treatment (within 4 weeks prior to screening) with imatinib mesylate (Gleevec)
Alanine aminotransferase or aspartate aminotransferase lab value that was greater than 1.5 x the upper limit of the normal range
Discontinued other ERA treatment for any adverse reaction other than those associated with liver function test abnormalities
