- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496207
A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) (PULSAR)
A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New South Wales
-
Darlinghurst, New South Wales, Australia, 2010
- St. Vincent's Hospital Sydney
-
Westmead, New South Wales, Australia, 2145
- Westmead Hospital
-
-
New South Whales
-
New Lambton, New South Whales, Australia, 2305
- John Hunter Hospital
-
-
Queensland
-
Chermside, Queensland, Australia, 4032
- Prince Charles Hospital
-
-
-
-
-
Cerqueira César, Brazil, 05403-900
- Instituto do Coração - HCFMUSP
-
Jardim Botânico, Brazil, 05403-900
- Hospital Sao Lucas da PUCRS
-
Sao Paulo, Brazil, 04037
- Hospital Sao Paulo
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30430
- Hospital Madre Teresa
-
-
Riogrande Do Sul
-
Porto Alegre, Riogrande Do Sul, Brazil, 90035
- Irmandade da Santa Casa de Misericordia de Porto Alegre
-
-
Santa Catarina
-
Blumenau, Santa Catarina, Brazil, 89010
- Hospital Dia do Pulmao
-
-
-
-
-
La Tronche, France, 38700
- CHU Michallon
-
Le Kremlin-Bicêtre, France, 94275
- Centre Hospitalier Universitaire de Bicêtre
-
Saint-Étienne, France, 42055
- Centre Hospitalier Universitaire de Saint Etienne
-
-
Hérault
-
Montpellier, Hérault, France, 34295
- Hopital Arnaud de Villeneuve
-
-
-
-
-
Dresden, Germany, 01307
- Universitätsklinikum Carl Gustav Carus an der TU Dresden
-
-
Niedersachsen
-
Hannover, Niedersachsen, Germany, 30625
- Medizinische Hochschule Hannover
-
-
Sachsen
-
Leipzig, Sachsen, Germany, 04103
- Universitätsklinikum Leipzig
-
-
Sachsen-Anhalt
-
Halle, Sachsen-Anhalt, Germany, 06120
- Universitätsklinikum Halle (Saale)
-
-
-
-
-
Ashkelon, Israel, 78278
- Barzilai Medical Center
-
Haifa, Israel, 34362
- Lady Davis Carmel Medical Center
-
Kefar Sava, Israel, 4428100
- Meir Medical Center
-
Petach-Tikva, Israel, 49100
- Rabin Medical Center - PPDS
-
Ramat Gan, Israel, 52621
- Chaim Sheba Medical Center
-
-
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
-
Barcelona, Spain, 08035
- Hospital Universitario Vall d'Hebron - PPDS
-
Madrid, Spain, 28041
- Hospital Universitario 12 De Octubre
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Hospital Universitario Marqués de Valdecilla
-
-
Madrid
-
Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro-Majadahonda
-
-
-
-
-
Clydebank, United Kingdom, G81 4DY
- Golden Jubilee National Hospital - PPDS
-
London, United Kingdom, NW32QG
- Royal Free London NHS Foundation Trust
-
London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust
-
-
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Pulmonary Associates, PA
-
Phoenix, Arizona, United States, 85012
- Arizona Pulmonary Specialists
-
Phoenix, Arizona, United States, 85381
- Banner-University Medical Center Phoenix
-
Tucson, Arizona, United States, 85724
- University of Arizona
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco Medical Center
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
-
Florida
-
Gainesville, Florida, United States, 32610
- UF Health Shands Hospital
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
-
Ohio
-
Cincinnati, Ohio, United States, 45129
- Lindner Clinical Trial Center
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Texas
-
Houston, Texas, United States, 77030
- Houston Methodist Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years
Documented diagnostic right heart catheterization (RHC) at any time prior to Screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group I: PAH in any of the following subtypes:
i. Idiopathic ii. Heritable PAH iii. Drug- or toxin-induced PAH iv. PAH associated with connective tissue disease v. PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following shunt repair
- Symptomatic pulmonary hypertension classified as WHO functional class II or III
- Screening RHC documenting a minimum PVR of ≥400 dyn·sec/cm5 (5 Wood units)
Pulmonary function tests (PFTs) within 6 months prior to Screening as follows:
- Total lung capacity (TLC) >70% predicted; or if between 60 to 70% predicted, or not possible to be determined, confirmatory high-resolution computed tomography (CT) indicating no more than mild interstitial lung disease (ILD), per investigator interpretation, or
- Forced expiratory volume (first second) (FEV1)/ forced vital capacity (FVC) >70% predicted
- Ventilation-perfusion (VQ) scan (or, if unavailable a negative CT pulmonary angiogram [CTPA] result, or pulmonary angiography result), any time prior to Screening Visit or conducted during the Screening Period, with normal or low probability result),
- No contraindication per investigator for RHC during the study
- 6MWD ≥150 and ≤550 meters repeated twice at Screening and both values within 15% of each other, calculated from the highest value
- PAH therapy at stable (per investigator) dose levels of SOC therapies
Exclusion Criteria:
- Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g, diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to study visit Cycle 1 Day 1 (C1D1)
- Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to study visit C1D1
- History of atrial septostomy within 180 days prior to Screening
- History of more than mild obstructive sleep apnea that is untreated
- Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C)
- History of human immunodeficiency virus infection-associated PAH
- Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536)
- Initiation of an exercise program for cardiopulmonary rehabilitation within 90 days prior to C1D1 or planned initiation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).
- Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) >160 mm Hg or sitting diastolic blood pressure >100 mm Hg during Screening Visit after a period of rest
- Systolic BP <90 mmHg during Screening or at baseline
- History of known pericardial constriction
- Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) >480 msec during Screening Period or C1D1
- Personal or family history of long QTc syndrome or sudden cardiac death
- Cerebrovascular accident within 3 months of C1D1
- History of restrictive or congestive cardiomyopathy
- Left ventricular ejection fraction (LVEF) <45% on historical echocardiogram (ECHO) within 6 months prior to Screening Period (or done as a part of the Screening Period) or pulmonary capillary wedge pressure (PCWP) >15 mmHg as determined in the Screening Period RHC.
- Any current or prior history of symptomatic coronary disease (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain)
- Acutely decompensated heart failure within 30 days prior to study visit C1D1, as per investigator assessment
- Significant (≥2+ regurgitation) mitral regurgitation (MR) or aortic regurgitation (AR) valvular disease
Any of the following clinical laboratory values during the Screening Period prior to C1D1:
- Baseline Hgb >16.0 g/dL
- Serum alanine aminotransferase or aspartate aminotransferase levels >3X upper limit of normal (ULN) or total bilirubin >1.5X ULN within 28 days of C1D1
- Estimated glomerular filtration rate <30 ml/min/1.73m2 (4-variable Modification of Diet in Renal Disease equation) within 28 days of C1D1 or required renal replacement therapy within 90 days
- WBC count <4000/mm3
- Platelets <100,000/μL
- Absolute neutrophil count <1500/mm3
- History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) within 6 months prior to Screening; serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to Screening
- History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in the investigational product
- Major surgery within 8 weeks prior to C1D1. Participants must have completely recovered from any previous surgery prior to C1D1.
- Prior heart or heart-lung transplants or life expectancy of <12 month
- Pregnant or breastfeeding females
- If on corticosteroids, and at any time in the last 30 days prior to the Screening Period: have been receiving doses of >20 mg/day of prednisone (or equivalent) or on a new or changing dose of ≤20 mg/day; only participants receiving stable doses of ≤20 mg prednisone (or equivalent) in last 30 days prior to the Screening Period permitted in the study
- History of active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤2 squamous cell carcinomas of the skin
- History of clinically significant (as determined by the investigator) non-PAH related cardiac, endocrine, hematologic, hepatic, (auto)immune, metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or another disease that may limit participation in the study. Autoimmune diseases are excluded with the exception of those related to PAH etiologies included in this study.
- Participation in another clinical trial involving intervention with another investigational drug, approved therapy for investigational use, or investigational device within 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer
- Weight >140 kg at Screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Participants will receive placebo plus SOC by SC injection during the 24-week treatment period.
Dosing will occur once every 3 weeks.
|
Placebo
SOC therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with endothelin-receptor antagonists, phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists.
|
Experimental: Sotatercept 0.3 mg/kg
Participants will receive sotatercept 0.3 mg/kg plus SOC by SC injection during the 24-week treatment period.
Per protocol, participants may have their doses titrated.
Dosing will occur once every 3 weeks.
|
SOC therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with endothelin-receptor antagonists, phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists.
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Other Names:
|
Experimental: Sotatercept 0.7 mg/kg
Participants will receive sotatercept 0.7 mg/kg plus SOC by SC injection during the 24-week treatment period.
Per protocol, participants may have their doses titrated.
Dosing will occur once every 3 weeks.
|
SOC therapy refers to approved PAH-specific medications and may consist of monotherapy or combination therapy with endothelin-receptor antagonists, phosphodiesterase 5 (PDE5) inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogues or receptor agonists.
Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Base Study: Change From Baseline in Pulmonary Vascular Resistance (PVR) at 24 Weeks
Time Frame: Baseline and 24 weeks
|
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and at 24 weeks.
|
Baseline and 24 weeks
|
Extension Period: Change From Baseline in PVR (Delayed-Start Analysis)
Time Frame: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
|
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
Extension Period: Change From Baseline in PVR (Placebo-Crossed Analysis)
Time Frame: Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
|
Each participant's PVR, at resting supine, was measured by right heart catheterization at baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
|
Baseline and the timepoint at which the third right heart catheterization was performed, which occurred between Month 18 and Month 24.
|
Extension Period: Number of Participants Who Experienced One or More Adverse Events (AEs)
Time Frame: Up to approximately 32 months
|
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
|
Up to approximately 32 months
|
Extension Period: Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to 30 months
|
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
|
Up to 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Base Study: Change From Baseline in 6-Minute Walk Distance (6MWD) at 24 Weeks
Time Frame: Baseline and 24 weeks
|
6MWD is measured by an exercise test known as 6-Minute Walk Test (6MWT) that assesses aerobic capacity and endurance.
It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity.
Each participant's 6MWD was measured at baseline and at 24 weeks.
An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
|
Baseline and 24 weeks
|
Base Study: Change From Baseline in Concentration of Amino-Terminal Brain Natriuretic Propeptide (NT-proBNP) at 24 Weeks
Time Frame: Baseline and 24 Weeks
|
Each participant's laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were measured at baseline and at 24 weeks.
|
Baseline and 24 Weeks
|
Base Study: Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at 24 Weeks
Time Frame: Baseline and 24 weeks
|
Each participant's TAPSE, which is commonly used to evaluate tricuspid valve annulus movement as an indicator of right heart function, was measured by echocardiography at baseline and 24 weeks.
|
Baseline and 24 weeks
|
Base Study: Change From Baseline in Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) Score at Cycle 9
Time Frame: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
The CAMPHOR is participant-reported questionnaire that contains 65 items in total, 25 relating to symptoms, 25 relating to quality of life (QoL), and 15 relating to activities.
Symptom items are scored from 0-25, with a higher score indicating worse symptoms.
QoL items are also scored from 0-25, with a higher score indicating a worse QoL and greater functional limitation.
Activity items are scored from 0-30, with a higher score indicating poorer functioning.
The combined score is obtained by summing up the symptoms score, QoL score and activity score.
The lowest combined score possible is 0, while the highest combined score possible is 80.
Each participant's CAMPHOR score was recorded at baseline and on Day 1 of Cycle 9.
|
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Base Study: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score
Time Frame: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
The SF-36 questionnaire is a participant-reported survey of a participant's health.
The survey evaluates 8 aspects of functional health and well-being that relate to either physical health or mental health.
The physical component summary is based primarily on physical functioning, bodily pain, and general health.
The mental component summary encompasses vitality, social functioning, and emotional and mental health.
Total scores for the physical component range from 0-100, with 100 representing the highest level of physical functioning.
The total scores for the mental component also range from 0-100, with 100 representing the highest level of mental functioning.
Each participant's SF-36 was recorded at baseline and on Day 1 of Cycle 9.
Each cycle was 21 days.
|
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Base Study: Number of Participants Who Experienced Events Indicative of Clinical Worsening of Pulmonary Arterial Hypertension (PAH)
Time Frame: Up to 24 weeks
|
Events that indicate clinical worsening of PAH include death, need for and/or worsening-related listing for lung and/or heart transplant, need to initiate an approved PAH SOC rescue therapy, PAH-specific hospitalization, or functional deterioration (worsened WHO Functional Class AND 15% decrease in 6MWD).
|
Up to 24 weeks
|
Base Study: Number of Participants Who Experienced an Improvement From Baseline in World Health Organization (WHO) Functional Class at 24 Weeks
Time Frame: Baseline and 24 Weeks
|
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms.
There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension.
|
Baseline and 24 Weeks
|
Base Study: Number of Participants Who Experienced One or More AEs
Time Frame: Up to 24 weeks
|
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
|
Up to 24 weeks
|
Base Study: Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to 24 weeks
|
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
|
Up to 24 weeks
|
Base Study: Change From Baseline in Body Mass Index (BMI) at Cycle 9
Time Frame: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Each participant's BMI was measured at baseline and at 24 weeks.
|
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Base Study: Change From Baseline in Systolic and Diastolic Blood Pressure at Cycle 9
Time Frame: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Each participant's systolic and diastolic blood pressure was taken at baseline and on Day 1 of Cycle 9.
Each cycle was 21 days.
|
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Base Study: Change From Baseline in Respiratory Rate at Cycle 9
Time Frame: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Each participant's respiratory rate (number of breaths per minute) was measured at baseline and on Day 1 of Cycle 9.
Each cycle was 21 days.
|
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Base Study: Change From Baseline in QTcF Interval at Cycle 9
Time Frame: Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Each participant's QTcF Interval was measured at baseline and on Day 1 of Cycle 9.
|
Baseline and Day 1 of Cycle 9, up to 24 weeks (Each cycle was 21 days.)
|
Base Study: Maximum Plasma Concentration (Cmax) of Sotatercept
Time Frame: Day 8 of Cycle 1 (Each cycle was 21 days.)
|
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Based on population pharmacokinetic (PopPK) modeling of previous sotatercept studies, Cmax occurs at Day 8 of Cycle 1 after a sotatercept dose is given.
The sotatercept concentration at Day 8 of Cycle 1 (each cycle was 21 days) is presented here as Cmax.
|
Day 8 of Cycle 1 (Each cycle was 21 days.)
|
Extension Period: Change From Baseline in 6MWD (Delayed-Start Analysis)
Time Frame: Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance.
It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity.
Each participant's 6MWD was measured at baseline and the timepoint at which the third RCH was performed.
This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured.
An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
|
Baseline and the timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
Extension Period: Change From Baseline in 6MWD (Placebo-Crossed Analysis)
Time Frame: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
6MWD is measured by an exercise test known as 6MWT that assesses aerobic capacity and endurance.
It measures the distance covered over a time of 6 minutes and is used as an outcome measure by which to compare changes in performance capacity.
Each participant's 6MWD was measured at baseline and the timepoint at which the third right heart catheterization was performed.
This occurred between Month 18 and Month 24, at which time each participant's 6MWD was also measured.
An increase in the distance walked during the 6MWT indicates improvement in basic mobility.
|
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
Extension Period: Number of Participants Who Experienced an Improvement From Baseline in WHO Functional Class (Delayed-Start Analysis)
Time Frame: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms.
There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension.
Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed.
This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
|
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
Extension Period: Change From Baseline in WHO Functional Class (Placebo-Crossed Analysis)
Time Frame: Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
The WHO Functional Class describes the severity of a person's pulmonary hypertension symptoms.
There are four different classes: I is the mildest and IV the most severe form of pulmonary hypertension.
Each participant's WHO Functional Class was assessed at baseline and the timepoint at which the third right heart catheterization was performed.
This occurred between Month 18 and Month 24, at which time each participant's WHO Functional Class was also assessed.
|
Baseline and timepoint at which third right heart catheterization was performed, which occurred between Month 18 and Month 24
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman A, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, Barnes J, Linde PG, de Oliveira Pena J, Badesch DB; PULSAR Trial Investigators. Sotatercept for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2021 Apr 1;384(13):1204-1215. doi: 10.1056/NEJMoa2024277.
- Humbert M, McLaughlin V, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Preston IR, Souza R, Waxman AB, Ghofrani HA, Escribano Subias P, Feldman J, Meyer G, Montani D, Olsson KM, Manimaran S, de Oliveira Pena J, Badesch DB. Sotatercept for the treatment of pulmonary arterial hypertension: PULSAR open-label extension. Eur Respir J. 2023 Jan 6;61(1):2201347. doi: 10.1183/13993003.01347-2022. Print 2023 Jan.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A011-09
- 2017-004738-27 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Arterial Hypertension
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
American Medical Association FoundationWithdrawnIdiopathic Pulmonary Arterial Hypertension.United States
-
Vanderbilt University Medical CenterRecruitingIdiopathic Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial Hypertension | Scleroderma Associated Pulmonary Arterial Hypertension | Appetite Suppressant Associate PAHUnited States
-
Gachon University Gil Medical CenterChonbuk National University Hospital; Samsung Medical Center; Pusan National... and other collaboratorsUnknownPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Deep Phenotyping | Heritable Pulmonary Arterial HypertensionKorea, Republic of
-
Amsterdam UMC, location VUmcZonMw: The Netherlands Organisation for Health Research and DevelopmentUnknown
-
Zhejiang UniversityUnknownIdiopathic Pulmonary Arterial HypertensionChina
-
Association de Recherche en Physiopathologie RespiratoireGlaxoSmithKline; Soladis; InterlisUnknownPulmonary Arterial Hypertension (PAH)France
-
Medical University of GrazLudwig Boltzmann Institute for Lung Vascular ResearchCompletedIdiopathic Pulmonary Arterial HypertensionAustria
-
Zhejiang UniversityCompletedIdiopathic Pulmonary Arterial HypertensionChina
-
Regina Steringer-MascherbauerUnknownPulmonary Arterial Hypertension WHO Group IAustria
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States