Pulmonary Arterial HypertensionPhase 2ARROWNCT02234141
Selonsertib in Adults With Pulmonary Arterial Hypertension
A Phase 2 study testing Selonsertib in people with Pulmonary Arterial Hypertension, run by Gilead Sciences at 46 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Selonsertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 46 sitesin 8 countries
- Study dates
- Nov 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
46 sites in 8 countries.
46 sites in 8 countries
United States24 sites
University of Michigan Health System
Ann Arbor, Michigan
The Emory Clinic
Atlanta, Georgia
University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavillion
Aurora, Colorado
Boston University Medical Center
Boston, Massachusetts
Tufts Medical Center
Boston, Massachusetts
University of Chicago Medicine
Chicago, Illinois
Cleveland Clinic
Cleveland, Ohio
Martha Morehouse Medical Pavilion
Columbus, Ohio
UT Southwestern Medical Center
Dallas, Texas
Inova Fairfax Medical Campus
Falls Church, Virginia
VA Greater Los Angeles Healthcare System
Los Angeles, California
University of Minnesota
Minneapolis, Minnesota
University of South Alabama Medical Center
Mobile, Alabama
Advanced Lung Disease Institute
Phoenix, Arizona
Arizona Pulmonary Specialist, Ltd
Phoenix, Arizona
Allegheny General Hospital
Pittsburgh, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania
Mayo Clinic
Rochester, Minnesota
Mary M. Parkes Center // University of Rochester Medical Center
Rochester, New York
University of California, Davis
Sacramento, California
University of California, San Francisco
San Francisco, California
Washington University School of Medicine
St Louis, Missouri
LA Biomedical Research Institute Harbor-UCLA Medical Center
Torrance, California
University of Arizona Clinical and Translational Science (CATS) Research Center
Tucson, Arizona
Germany6 sites
Klinik III fur Innere Medizin, Herzzentrum Uniklinik Koln
Cologne
Universitätsklinikum Carl Gustav Carus
Dresden
Universitatsklinikul Giessen und Marburg GmbH
Giessen, Hesse
Medizinische Hochschule Hannover
Hanover
Universitatsklinikum Leipzig
Leipzig
Klinik und Poliklinik fur Innere Medizin II, Universitatsklinikum Regensburg
Regensburg
Canada5 sites
Peter Lougheed Center
Calgary, Alberta
Victoria Hospital - London Health Sciences Centre
London, Ontario
Institut Universitaire de caridologie et de pneumologie de Quebee (IUCPQ)
Sainte-Foy, Quebec
University Health Network
Toronto, Ontario
Vancouver General Hospital, The Lung Centre // Vancouver Coastal Health, Vancouver General Hospital
Vancouver, British Columbia
France3 sites
CHU de Grenoble Clinique Universitaire de Pneumologie
Grenoble
CHU de Bicetre, Service de Pneumologie-Reanimation Respiratoire
Le Kremlin-Bicêtre
Hopital Cardiologique-CHRU Lille, Service de cardiologie
Lille
Spain3 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario Doce (12) de Octubre
Madrid
United Kingdom3 sites
Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital
Clydebank, West Dunbartonshire
Royal Free Hampstead NHS Trust
London
Clinical Research Facility, Royal Hallamshrie Hospital
Sheffield
About this study
Official title: A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Placebo, Selonsertib
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called GS-4997
Tablet administered orally once daily
SelonsertibDrug
Also called GS-4997
Tablets administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Selonsertib 2 mg | Experimental | Participants will receive selonsertib 2 milligrams (mg) for 24 weeks and may continue on this dose during the long-term treatment phase. Receives: Drug: Selonsertib |
| Selonsertib 6 mg | Experimental | Participants will receive selonsertib 6 mg for 24 weeks and may continue on this dose during the long-term treatment phase. Receives: Drug: Selonsertib |
| Selonsertib 18 mg | Experimental | Participants will receive selonsertib 18 mg for 24 weeks and may continue on this dose during the long-term treatment phase. Receives: Drug: Selonsertib |
| Placebo | Experimental | Participants will receive selonsertib placebo for 24 weeks, and may then be rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase. Receives: Drug: Placebo; Drug: Selonsertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC)
PVR is a measure of the extent to which pulmonary circulation resists cardiac output. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Secondary outcomes (18)
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Cardiac Index
Cardiac index is the amount of blood pumped by the heart, per minute, per meter square of body surface area. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mPAP
mPAP is the mean blood pressure in the pulmonary artery. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mRAP
mRAP is the mean blood pressure in the right atrium of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Mixed Venous Oxygen Saturation (SVO2) (%)
SVO2 is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Right Ventricular Cardiac Power (RVCP)
RVCP is a cardiopulmonary hemodynamic assessment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in 6MWD Test
The 6MWD test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. It measures the distance a participant is able to walk in a period of six minutes. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in BDI After the 6MWD Test
Immediately following completion of the 6-minute walk test, participants were asked to assess breathlessness using the BDI score as follows: 0 = no breathlessness, 10 = extremely strong (maximal breathlessness), any number > 10 = Highest possible. Therefore, the minimum for BDI score was 0 and there was no upper bound. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Number of Participants Experiencing Change From Baseline at Week 24 in WHO Functional Class
Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g., doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most participants also have edema in the feet and ankles as result of right heart failure. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in NT-proBNP
NT-proBNP is used to detect, diagnose, and evaluate the severity of heart failure. In general, NT-proBNP levels are higher in participants with heart failure than those who have normal heart function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Short Form (SF-36) Physical Functioning Scale
Quality of life was assessed using the SF-36 questionnaire, a self-administered multi-item survey that asks 36 questions to measure functional health and well-being from the participant's point of view and consists of eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) as well as 2 summary measures (Physical Health and Mental Health). Data presented are for 1 of the domains only: Physical Functioning. Scores can range from 0 to 100, with a higher score representing a higher level of functioning. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in emPHasis-10 Questionnaire Score
Quality of life was assessed using the emPHasis-10 questionnaire, a disease-specific self-administered 10-question questionnaire designed for routine assessment of health-related quality of life in pulmonary hypertension. Total score can range from 0 to 50, with higher scores indicating a worse quality of life. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline at Week 24 in Heart Rate Recovery (HRR) After the 6MWD Test
HRR was assessed after the 6MWD test. The HRR was calculated as the difference between the heart rate measured immediately after completing the 6MWD test and the second heart rate measured 1 minute after the 6MWD test. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Kaplan-Meier Estimate of Time to Clinical Worsening (TTCW) Evaluated in Period 1
TTCW was defined as time to the first occurrence of: death (all-cause), hospitalization for worsening pulmonary arterial hypertension (PAH) (any hospitalization for worsening PAH, lung or heart/lung transplant, atrial septostomy, or initiation of continuously infused prostanoid therapy), or disease progression (defined as both > 15% decrease from baseline in 6MWD test and WHO class III or IV symptoms at two consecutive postbaseline clinic visits separated by ≥ 14 days). TTCW was evaluated using Kaplan-Meier estimates.
Measured: Baseline up to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: TAPSE
TAPSE is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Myocardial Strain (%)
Right ventricular myocardial strain is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Tricuspid Annular Peak Sys Myocard Velocity (TAS)
TAS is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Tei Index (RVTI)
The Tei-index is defined as the sum of the isovolumic contraction and the isovolumic relaxation time divided by ejection time, and thus incorporates elements of both systolic and diastolic phases in the assessment of global ventricular function. An increased Tei-index results from ventricular dysfunction and provides prognostic information for a variety of myocardial conditions. The RVTI is a candidate to increase the non-invasive diagnosis of PAH because it reflects the right ventricular function, is easy to assess, and can be estimated in the same session as the echocardiographic PAP. The normal value of the RVTI is 0.28 +/- 0.04. An increased RVTI is associated with either left ventricular diastolic abnormalities or pulmonary hypertension. This score has no bounds. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Fractional Area Change (RVFAC)
RVFAC is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234141
- Sponsor's protocol ID
- GS-US-357-1394
- Other IDs
- 2014-002131-34, 2014
- Acronym
- ARROW
- Status last verified
- Mar 2019
- First submitted
- 2 Sep 2014
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rosenkranz S, Feldman J, McLaughlin VV, Rischard F, Lange TJ, White RJ, Peacock AJ, Gerhardt F, Ebrahimi R, Brooks G, Satler C, Frantz RP; ARROW Study Group. Selonsertib in adults with pulmonary arterial hypertension (ARROW): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Respir Med. 2022 Jan;10(1):35-46. doi: 10.1016/S2213-2600(21)00032-1. Epub 2021 Aug 20.
PubMed 34425071
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02234141
- Acronym / sponsor ID
- ARROW / GS-US-357-1394
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Selonsertib 2 mg | Experimental | Drug: SelonsertibParticipants will receive selonsertib 2 milligrams (mg) for 24 weeks and may continue on this dose during the long-term treatment phase. |
| Selonsertib 6 mg | Experimental | Drug: SelonsertibParticipants will receive selonsertib 6 mg for 24 weeks and may continue on this dose during the long-term treatment phase. |
| Selonsertib 18 mg | Experimental | Drug: SelonsertibParticipants will receive selonsertib 18 mg for 24 weeks and may continue on this dose during the long-term treatment phase. |
| Placebo | Experimental | Drug: Placebo, Drug: SelonsertibParticipants will receive selonsertib placebo for 24 weeks, and may then be rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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:
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: GS-4997Tablet administered orally once daily | Drug | Placebo |
| SelonsertibAlso: GS-4997Tablets administered orally once daily | Drug | Placebo, Selonsertib 18 mg, Selonsertib 2 mg, Selonsertib 6 mg |
Primary outcome
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC)
Time frame: Baseline to Week 24
PVR is a measure of the extent to which pulmonary circulation resists cardiac output. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.
18 secondary outcomes
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Cardiac Index
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mPAP
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mRAP
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Mixed Venous Oxygen Saturation (SVO2) (%)
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Right Ventricular Cardiac Power (RVCP)
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in 6MWD Test
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in BDI After the 6MWD Test
Time frame: Baseline to Week 24
Number of Participants Experiencing Change From Baseline at Week 24 in WHO Functional Class
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in NT-proBNP
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Short Form (SF-36) Physical Functioning Scale
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in emPHasis-10 Questionnaire Score
Time frame: Baseline to Week 24
Change From Baseline at Week 24 in Heart Rate Recovery (HRR) After the 6MWD Test
Time frame: Baseline to Week 24
Kaplan-Meier Estimate of Time to Clinical Worsening (TTCW) Evaluated in Period 1
Time frame: Baseline up to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: TAPSE
Time frame: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Myocardial Strain (%)
Time frame: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Tricuspid Annular Peak Sys Myocard Velocity (TAS)
Time frame: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Tei Index (RVTI)
Time frame: Baseline to Week 24
Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Fractional Area Change (RVFAC)
Time frame: Baseline to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34425071Rosenkranz S, Feldman J, McLaughlin VV, Rischard F, Lange TJ, White RJ, Peacock AJ, Gerhardt F, Ebrahimi R, Brooks G, Satler C, Frantz RP; ARROW Study Group. Selonsertib in adults with pulmonary arterial hypertension (ARROW): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Respir Med. 2022 Jan;10(1):35-46. doi: 10.1016/S2213-2600(21)00032-1. Epub 2021 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selonsertib in people with Pulmonary Arterial Hypertension, run by Gilead Sciences at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Germany, Canada, France, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC) (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02234141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.