Status:
COMPLETED
Selonsertib in Adults With Pulmonary Arterial Hypertension
Lead Sponsor:
Gilead Sciences
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug- and toxin-induced PAH, or PAH associated with connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital heart defects (repaired greater than 1 year prior to Screening)
- Meet all of the following hemodynamic criteria by means of a screening right heart catheterization (RHC) completed prior to randomization:
- Mean pulmonary artery pressure (mPAP) of greater than or equal to (≥) 25 millimeters of mercury (mm Hg)
- Pulmonary vascular resistance (PVR) ≥ 400 dyne\* second/centimeter\^5 (dynes\*sec/cm\^5)
- Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) of less than or equal to (≤) 12 mm Hg if PVR ≥ 400 and less than (\<) 500 dynes\*sec/cm\^5, or PCWP/LVEDP ≤ 15 mm Hg if PVR ≥ 500 dynes•sec/cm\^5
- Be able to walk a distance of at least 100 meters
- Have World Health Organization (WHO) Functional Class II or III symptoms
- Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:
- Forced expiratory volume in one second (FEV1) ≥ 55 percent (%) of predicted normal
- FEV1: forced vital capacity (FVC) ratio ≥ 0.60
- Receiving treatment with one or more drugs approved for PAH for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks
- Key
Exclusion
- Diagnosis of PAH associated with significant venous or capillary involvement (PCWP greater than \[\>\] 15 mm Hg), pulmonary capillary hemangiomatosis, portal hypertension, or unrepaired congenital heart defects
- Pulmonary hypertension (PH) belonging to groups 2 to 5 of the 2013 NICE classification
- Left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant ischemic, valvular or constrictive heart disease
- Uncontrolled hypertension (≥ 180/110 mm Hg) at Screening
- End stage renal disease (receiving peritoneal dialysis, hemodialysis, or status after renal transplantation)
- Severe liver disease (Child-Pugh Class C, with or without cirrhosis)
- Individuals may be rescreened one additional time with prior notification to and approval by the sponsor.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT02234141
Start Date
November 1 2014
End Date
December 1 2016
Last Update
April 10 2019
Active Locations (46)
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1
University of South Alabama Medical Center
Mobile, Alabama, United States
2
Advanced Lung Disease Institute
Phoenix, Arizona, United States
3
Arizona Pulmonary Specialist, Ltd
Phoenix, Arizona, United States
4
University of Arizona Clinical and Translational Science (CATS) Research Center
Tucson, Arizona, United States