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Selonsertib in Adults With Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Selonsertib in Adults With Pulmonary Arterial Hypertension

A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension

NCT02234141•Gilead Sciences

View on ClinicalTrials.gov

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 arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+1 more criteria

Exclusion Criteria

•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.

Locations (46)

University of South Alabama Medical Center

Mobile, Alabama, United States

Advanced Lung Disease Institute

Phoenix, Arizona, United States

Arizona Pulmonary Specialist, Ltd

Phoenix, Arizona, United States

University of Arizona Clinical and Translational Science (CATS) Research Center

Tucson, Arizona, United States

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

University of California, Davis

Sacramento, California, United States

University of California, San Francisco

San Francisco, California, United States

LA Biomedical Research Institute Harbor-UCLA Medical Center

Torrance, California, United States

University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavillion

Aurora, Colorado, United States

The Emory Clinic

Atlanta, Georgia, United States

Key Dates

Start Date

November 1, 2014

Primary Completion Date

April 1, 2016

Completion Date

December 1, 2016

Last Updated

April 10, 2019

Enrollment

151

ACTUAL participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Placebo

DRUG

Selonsertib

DRUG

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

NCT07218029

Pulmonary Arterial Hypertension

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RECRUITINGPHASE1/PHASE2

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

NCT06649110

Healthy Volunteers, Pulmonary Arterial Hypertension

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Selonsertib in Adults With Pulmonary Arterial Hypertension

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization