Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04796337
Other study ID # 7962-004
Secondary ID A011-122020-0050
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 12, 2021
Est. completion date November 30, 2027

Study information

Verified date June 2024
Source Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.


Description:

Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date November 30, 2027
Est. primary completion date September 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early - Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements - Must have the ability to understand and provide documented informed consent - Females of childbearing potential must: - Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug - If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug - Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug - Male participants must: - Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy - Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug - Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study Exclusion Criteria: - Did not participate in a sotatercept PAH parent trial - Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. - Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept - Pregnant or breastfeeding females

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Sotatercept
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.

Locations

Country Name City State
Argentina Hospital Universitario Austral ( Site 1901) Buenos Aires
Argentina Cardiologia Palermo ( Site 1911) Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Centro Medico Dra De Salvo ( Site 1904) Ciudad Autonoma de Buenos Aires Caba
Argentina Sanatorio Allende ( Site 1908) Cordoba
Argentina Instituto Médico DAMIC ( Site 1909) Córdoba Cordoba
Argentina Instituto de Investigaciones Clinicas Quilmes ( Site 1903) Quilmes Buenos Aires
Argentina Instituto Medico Rio Cuarto ( Site 1907) Rio Cuarto Cordoba
Argentina Centro Oncologico de Rosario ( Site 1905) Rosario Santa Fe
Argentina Hospital Provincial del Centenario ( Site 1912) Rosario Santa Fe
Argentina Instituto Cardiovascular de Rosario ( Site 1906) Rosario Santa Fe
Argentina Hospital Dr. Jose Maria Cullen ( Site 1902) Santa Fe
Australia Royal Adelaide Hospital ( Site 1109) Adelaide South Australia
Australia The Prince Charles Hospital ( Site 1104) Brisbane Queensland
Australia Royal Prince Alfred Hospital ( Site 1106) Camperdown New South Wales
Australia Saint Vincents Hospital Sydney ( Site 1102) Darlinghurst New South Wales
Australia Royal Hobart Hospital ( Site 1107) Hobart Tasmania
Australia John Hunter Hospital ( Site 1101) New Lambton New South Wales
Australia Fiona Stanley Hospital ( Site 1103) Perth Western Australia
Australia Princess Alexandra Hospital ( Site 1108) Woolloongabba Queensland
Austria Medizinische Universität Graz ( Site 2003) Graz Steiermark
Austria Medizinische Universitat Innsbruck ( Site 2004) Innsbruck Tirol
Austria Ordensklinikum Linz GmbH Elisabethinen ( Site 2002) Linz Oberosterreich
Austria Medizinische Universitat Wien ( Site 2001) Wien
Belgium Erasme Hospital ( Site 1402) Bruxelles Bruxelles-Capitale, Region De
Belgium UZ Leuven - Campus Gasthuisberg ( Site 1401) Leuven Vlaams-Brabant
Brazil Hospital Madre Teresa ( Site 1804) Belo Horizonte Minas Gerais
Brazil Hospital Dia do Pulmao ( Site 1802) Blumenau Santa Catarina
Brazil Hospital São Lucas da PUCRS ( Site 1801) Porto Alegre Rio Grande Do Sul
Brazil Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805) Porto Alegre Rio Grande Do Sul
Brazil Instituto do Coracao - HCFMUSP ( Site 1803) Sao Paulo
Brazil Hospital Sao Paulo ( Site 1806) São Paulo Sao Paulo
Canada Peter Lougheed Centre ( Site 2102) Calgary Alberta
Canada University of Alberta Hospital ( Site 2101) Edmonton Alberta
Canada St. Joseph's Healthcare Hamilton ( Site 2105) Hamilton Ontario
Canada Sir Mortimer B Davis Jewish General Hospital ( Site 2103) Montreal Quebec
Canada St Boniface General Hospital ( Site 2106) Winnepeg Manitoba
Colombia Fundacion Neumologica Colombiana ( Site 3403) Bogota Cundinamarca
Colombia Fundacion Valle del Lili ( Site 3401) Cali Valle Del Cauca
Colombia Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402) Medellin Antioquia
Colombia Centro Medico Imbanaco de Cali S.A ( Site 3404) Santiago de Cali Valle Del Cauca
Croatia Klinicki Bolnicki Centar Split ( Site 3901) Split Splitsko-dalmatinska Zupanija
Croatia Klinicki Bolnicki Centar Zagreb ( Site 3902) Zagreb Zagrebacka Zupanija
Czechia Vseobecna fakultni nemocnice v Praze-Centrum srdecního selhání ( Site 2201) Praha 2
Czechia Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202) Praha 4
Denmark Aarhus Universitetshospital, Skejby ( Site 3801) Aarhus Midtjylland
Denmark Rigshospitalet ( Site 3802) København Ø Hovedstaden
France CHU Angers ( Site 1313) Angers Maine-et-Loire
France Hopital Cavale Blanche ( Site 1314) Brest Finistere
France Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317) Bron Rhone-Alpes
France CHU Caen Normandie ( Site 1325) Caen Calvados
France C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303) La Tronche Isere
France CHU - Hopital de Bicetre ( Site 1304) Le Kremlin Bicetre Val-de-Marne
France CHRU Lille ( Site 1306) Lille Nord
France Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301) Montpellier Herault
France Hopital Nord Laennec ( Site 1309) Nantes Loire-Atlantique
France Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311) Nice Alpes-Maritimes
France Groupe Hospitalier Sud ( Site 1312) Pessac Gironde
France CHU de la Miletrie Poitiers ( Site 1316) Poitiers Vienne
France Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302) Saint-Priest-en-Jarez Loire
France Hopital Civil - CHU Strasbourg ( Site 1307) Strasbourg Bas-Rhin
France CHU de Toulouse - Hopital Larrey ( Site 1315) Toulouse Haute-Garonne
France C.H.U. de Tours - Hopital Bretonneau ( Site 1310) Tours Indre-et-Loire
France C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308) Vandoeuvre Les Nancy Meurthe-et-Moselle
Germany DRK Kliniken Berlin Westend ( Site 1507) Berlin
Germany Universitätsklinik Köln ( Site 1511) Cologne Nordrhein-Westfalen
Germany Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501) Dresden Sachsen
Germany Universitätsklinikum Gießen und Marburg GmbH ( Site 1512) Gießen Hessen
Germany Universitätsklinikum Halle ( Site 1502) Halle Sachsen-Anhalt
Germany Medizinische Hochschule Hannover ( Site 1505) Hannover Niedersachsen
Germany Thoraxklinik-Heidelberg gGmbH ( Site 1509) Heidelberg Baden-Wurttemberg
Germany Universataet des Saarlandes ( Site 1513) Homburg Saarland
Germany Universitatsklinikum Leipzig ( Site 1508) Leipzig Sachsen
Germany Krankenhaus Neuwittelsbach ( Site 1510) München Bayern
Germany Universitaetsklinik Regensburg ( Site 1503) Regensburg Bayern
Greece Attikon University General Hospital of Athens ( Site 3604) Athens Attiki
Greece Onassis Cardiac Surgery Center ( Site 3602) Athens Attiki
Greece Evangelismos General Hospital of Athens ( Site 3605) Athina Attiki
Greece AHEPA University General Hospital of Thessaloniki ( Site 3601) Thessaloniki
Israel Assuta Ashdod Medical Center ( Site 1710) Ashdod
Israel Barzilai Medical Center ( Site 1708) Ashkelon
Israel Lady Davis Carmel Medical Center ( Site 1705) Haifa
Israel Hadassah Medical Center ( Site 1711) Jerusalem
Israel Meir Medical Center ( Site 1707) Kfar Saba
Israel Rabin Medical Center ( Site 1703) Petach Tikvah
Israel Sheba MC ( Site 1701) Ramat Gan
Italy Ospedale S. Giuseppe Multimedica ( Site 2403) Milano Lombardia
Italy Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406) Monza Lombardia
Italy Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407) Napoli
Italy Universita "La Sapienza" Policlinico Umberto I ( Site 2402) Roma
Italy Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405) Trieste Friuli-Venezia Giulia
Korea, Republic of Chonnam National University Hospital ( Site 3105) Gwangju Kyonggi-do
Korea, Republic of Gachon University Gil Medical Center ( Site 3103) Incheon
Korea, Republic of Samsung Medical Center ( Site 3106) Seoul
Korea, Republic of Seoul National University Hospital ( Site 3102) Seoul
Korea, Republic of The Catholic University Seoul St. Mary's Hospital ( Site 3104) Seoul
Mexico Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503) Ciudad de Mexico Distrito Federal
Mexico Hospital Angeles Lomas ( Site 2501) Huixquilucan
Mexico Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504) Monterrey Nuevo Leon
Mexico Unidad de Investigación Clínica en Medicina, S.C ( Site 2505) Sertoma Nuevo Leon
Netherlands VU Medisch Centrum ( Site 2601) Amsterdam Noord-Holland
Netherlands Maastricht University Medical Center ( Site 2603) Maastricht Limburg
Netherlands Radboud University Nijmegen Medical Centre ( Site 2605) Nijmegen Gelderland
Netherlands Erasmus MC ( Site 2604) Rotterdam Zuid-Holland
New Zealand Greenlane Clinical Centre ( Site 2703) Auckland
New Zealand Waikato District Health Board ( Site 2702) Hamilton Waikato
Poland Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801) Krakow Malopolskie
Poland Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802) Otwock Mazowieckie
Portugal Hospital Garcia de Orta ( Site 3501) Almada Setubal
Portugal Centro Hospitalar E Universitário De Coimbra ( Site 3502) Coimbra
Portugal Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503) Lisboa
Serbia Clinical Center of Serbia ( Site 2901) Beograd
Serbia Institute of Cardiovascular Diseases Dedinje ( Site 2903) Beograd
Serbia Clinical Center Kragujevac ( Site 2905) Kragujevac Sumadijski Okrug
Serbia University Clinical Center Nis ( Site 2904) Nis Nisavski Okrug
Serbia Institute for pulmonary diseases of Vojvodina ( Site 2906) Sremska kamenica Juznobacki Okrug
Spain Hospital Clinic de Barcelona ( Site 1602) Barcelona
Spain Hospital Universitari Vall d'Hebron ( Site 1605) Barcelona
Spain Hospital Universitario 12 de Octubre ( Site 1603) Madrid
Spain Hospital Universitario La Paz ( Site 1610) Madrid
Spain Hospital Universitario Ramon y Cajal ( Site 1609) Madrid
Spain Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604) Majadahonda Madrid
Spain Hospital Universitario de Son Espases ( Site 1611) Palma de Mallorca Islas Baleares
Spain Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608) Salamanca
Spain Hospital Universitario Marques de Valdecilla ( Site 1601) Santander Cantabria
Spain Hospital Universitario de Toledo ( Site 1607) Toledo
Sweden Sahlgrenska Universitetssjukhuset ( Site 3201) Goteburg Vastra Gotalands Lan
Sweden Skanes Universitetssjukhus Lund ( Site 3203) Lund Skane Lan
Sweden Norrlands Universitetssjukhus ( Site 3205) Umea Vasterbottens Lan
Sweden Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204) Uppsala Uppsala Lan
Switzerland Universitaetsspital Zurich ( Site 3301) Zurich
Taiwan Kaohsiung Veterans General Hospital ( Site 3702) Kaohsiung
Taiwan China Medical University Hospital ( Site 3701) Taichung
Taiwan National Cheng Kung University Hospital ( Site 3703) Tainan
United Kingdom Royal Papworth Hospital ( Site 1208) Cambridge Cambridgeshire
United Kingdom Golden Jubilee National Hospital ( Site 1204) Glasgow Glasgow City
United Kingdom Imperial College Healthcare NHS Trust ( Site 1203) London London, City Of
United Kingdom Royal Brompton Hospital ( Site 1206) London England
United Kingdom Royal Free London NHS Foundation Trust ( Site 1202) London London, City Of
United Kingdom The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205) Newcastle Upon Tyne
United Kingdom Royal Hallamshire Hospital ( Site 1207) Sheffield North Yorkshire
United States University of New Mexico Health Sciences Center ( Site 1048) Albuquerque New Mexico
United States University of Michigan ( Site 1011) Ann Arbor Michigan
United States Emory University ( Site 1030) Atlanta Georgia
United States University of Colorado Hospital ( Site 1013) Aurora Colorado
United States Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036) Baltimore Maryland
United States Brigham & Women's Hospital ( Site 1014) Boston Massachusetts
United States Tufts Medical Center - PPDS ( Site 1012) Boston Massachusetts
United States The University of North Carolina at Chapel Hill ( Site 1042) Chapel Hill North Carolina
United States The Lindner Center for Research and Education at The Christ Hospital ( Site 1001) Cincinnati Ohio
United States University of Cincinnati Medical Center ( Site 1035) Cincinnati Ohio
United States Cleveland Clinic Foundation ( Site 1065) Cleveland Ohio
United States The Ohio State University Wexner Medical Center ( Site 1032) Columbus Ohio
United States University of Texas Southwestern Medical Center ( Site 1038) Dallas Texas
United States Duke University Medical Center ( Site 1026) Durham North Carolina
United States CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044) Houston Texas
United States Houston Methodist Hospital ( Site 1009) Houston Texas
United States University of Iowa Hospital and Clinics ( Site 1050) Iowa City Iowa
United States Mayo Clinic Jacksonville - PPDS ( Site 1045) Jacksonville Florida
United States University of Kansas Medical Center ( Site 1020) Kansas City Missouri
United States Statcare Pulmonary Consultants - Knoxville ( Site 1031) Knoxville Tennessee
United States University of California San Diego ( Site 1002) La Jolla California
United States David Geffen School of Medicine at UCLA ( Site 1068) Los Angeles California
United States Norton Pulmonary Specialists ( Site 1066) Louisville Kentucky
United States Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) Milwaukee Wisconsin
United States University of Minnesota ( Site 1062) Minneapolis Minnesota
United States Medical University of South Carolina - PPDS ( Site 1003) Mount Pleasant South Carolina
United States Vanderbilt University Medical Center ( Site 1027) Nashville Tennessee
United States New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046) New York New York
United States Integris Health, Inc. ( Site 1084) Oklahoma City Oklahoma
United States University of Nebraska Medical Center ( Site 1053) Omaha Nebraska
United States University of California Irvine ( Site 1086) Orange California
United States AdventHealth Orlando ( Site 1058) Orlando Florida
United States Arizona Pulmonary Specialists ( Site 1010) Phoenix Arizona
United States Pulmonary Associates, PA ( Site 1008) Phoenix Arizona
United States UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059) Pittsburgh Pennsylvania
United States The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054) Portland Oregon
United States Rhode Island Hospital ( Site 1033) Providence Rhode Island
United States Renown Regional Medical Center ( Site 1055) Reno Nevada
United States University of Rochester Medical Center - PPDS ( Site 1039) Rochester New York
United States UC Davis - Medial Center ( Site 1064) Sacramento California
United States Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022) Saint Louis Missouri
United States University of Utah - PPDS ( Site 1049) Salt Lake City Utah
United States University of California San Francisco ( Site 1019) San Francisco California
United States Jeffrey S.Sager MD Medical Corporation ( Site 1060) Santa Barbara California
United States University of Washington Medical Center ( Site 1067) Seattle Washington
United States University of South Florida ( Site 1043) Tampa Florida
United States Harbor UCLA Medical Center ( Site 1028) Torrance California
United States University of Arizona ( Site 1006) Tucson Arizona
United States The George Washington University Medical Faculty Associates ( Site 1025) Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Serbia,  Spain,  Sweden,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Who Experience an Adverse Event (AE) AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who experience an AE will be reported. Up to approximately 50 months
Primary Number of Participants Who Discontinue Study Treatment Due to an AE AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who discontinue study treatment due to an AE will be reported. Up to approximately 50 months
Primary Number of Participants with Detectable Anti-Drug Antibodies (ADAs) ADAs will be detected in serum. The number of participants with detectable ADAs will be presented. Up to approximately 50 months
Primary Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months. Up to approximately 50 months
Primary Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP, sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months. Up to approximately 50 months
Primary Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH) Blood samples will be collected to determine concentration of FSH level at designated time points up to approximately 50 months. Up to approximately 50 months
Primary Change From Baseline in Body Weight Change from baseline in body weight will be reported at designated time points up to approximately 48 months. Baseline and up to approximately 48 months
Primary Change From Baseline in Blood Pressure Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months. Baseline and up to approximately 48 months
Primary Change From Baseline in Electrocardiogram (ECG) Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months. Baseline and up to approximately 48 months
Primary Laboratory parameters (Urinalysis): pH, Specific Gravity, Protein, Glucose, Bilirubin, Ketones, Blood, Leukocyte Esterase, Urobilinogen, and Nitrite Urine samples will be collected to determine pH, specific gravity, protein, glucose, bilirubin, ketones, blood, leukocyte esterase, urobilinogen, and nitrite at designated timepoints up to approximately 48 months. Up to approximately 48 months
Secondary Change From Baseline in 6-Minute Walk Distance (6MWD) The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). The change from baseline in 6MWD will be reported. Baseline and up to approximately 48 months
Secondary Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP level will be reported. Baseline and up to approximately 48 months
Secondary Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC) The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The change from baseline in the percentage of participants who improve in WHO FC will be reported. Baseline and up to approximately 48 months
Secondary Change From Baseline in Pulmonary Vascular Resistance (PVR) PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). The change from baseline in PVR will be reported. Baseline and up to approximately 48 months
Secondary Overall Survival (OS) Overall survival is defined as the time from the start of the first sotatercept treatment in the individual participant's parent study or in this study, if the participant was completely on placebo in the parent study, to the date of death in this study, regardless of the actual cause of the participant's death. Up to approximately 78 months
Secondary Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator will be reported. Baseline and up to approximately 48 months
Secondary Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score The Borg CR 10 Scale assesses the severity of shortness of breath as perceived by the participant. Participants will be asked: How much difficulty is your breathing causing you right now?". The score of the item ranges from 0 (no difficulty in breathing) to10 (maximum difficulty in breathing). Higher score indicates more severe dyspnea. The change from baseline in Borg CR10 scale score will be reported. Baseline and up to approximately 48 months
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00963001 - Effect of Food on the Pharmacokinetics of Oral Treprostinil Phase 1
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3