A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA.
Ioana R Preston, David Badesch, Hossein-Ardeschir Ghofrani...
https://pubmed.ncbi.nlm.nih.gov/39978862Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07218029
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension Therapy
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
815
Participants Needed
116
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating new treatments for Pulmonary Arterial Hypertension (PAH), a condition where the blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and making it difficult for the heart to work properly. PAH can lead to breathing difficulties and reduced activity levels. While current treatments help manage symptoms, they do not stop the disease from progressing. Sotatercept is a study medicine designed to target specific proteins involved in PAH, and this long-term follow-up study aims to assess its safety and tolerability when used alongside standard PAH treatments over an extended period. Participants who have completed previous sotatercept PAH studies may join this open-label follow-up study. Those from blinded studies will start sotatercept at 0.3 mg/kg by subcutaneous injection every three weeks and may increase to 0.7 mg/kg. Participants from unblinded studies will continue their current dose and may also increase to 0.7 mg/kg. The study focuses on monitoring sotatercept use combined with background PAH therapy to observe long-term effects. Throughout the study, participants will undergo regular assessments including tracking adverse events, laboratory tests for blood and chemistry markers, body weight, blood pressure, and electrocardiograms up to approximately 7 years. Additional measurements include walking distance tests, heart function markers, and risk scores related to PAH. Safety monitoring and tolerance to the medication will be closely observed over time to better understand sotatercept’s long-term impact in managing PAH.
CONDITIONS
Brief Title
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Completed a prior PAH sotatercept clinical study without early discontinuation
- Willing to follow the study visit schedule and comply with protocol requirements
- Able to understand and provide documented informed consent
You will not qualify if you...
- Did not participate in a sotatercept PAH parent study
- Missed more than 4 consecutive doses of sotatercept between the end of the parent study and the start of this study
- Has an ongoing serious adverse event from a prior sotatercept study possibly related to sotatercept
- Female who is pregnant or breastfeeding
- Immediate family member is study staff or Sponsor staff involved in this study
- Currently enrolled in another investigational product study other than a sotatercept study
- Is incapacitated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 90 months
Participants receive sotatercept subcutaneous injections every 3 weeks with dose adjustments up to 0.7 mg/kg for the remainder of the study.
Visits every 3 weeks for sotatercept injection and assessments
Trial Site Locations
Total: 116 locations
1
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States, 85032
Active, Not Recruiting
2
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
University of California San Diego Health ( Site 1002)
La Jolla, California, United States, 92039
Active, Not Recruiting
4
UC Irvine Health Medical Center ( Site 1086)
Orange, California, United States, 92868
Actively Recruiting
5
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
San Francisco, California, United States, 94143
Active, Not Recruiting
6
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States, 93105-5316
Actively Recruiting
7
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
Torrance, California, United States, 90502
Active, Not Recruiting
8
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States, 80045
Active, Not Recruiting
9
Mayo Clinic Jacksonville ( Site 1045)
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
10
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States, 32803
Actively Recruiting
11
University of Kansas Medical Center ( Site 1020)
Kansas City, Kansas, United States, 66160
Actively Recruiting
12
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States, 40202
Actively Recruiting
13
Johns Hopkins University ( Site 1036)
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Tufts Medical Center ( Site 1012)
Boston, Massachusetts, United States, 02111
Actively Recruiting
15
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States, 68198-5990
Active, Not Recruiting
16
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States, 10021
Active, Not Recruiting
17
Duke University Medical Center ( Site 1026)
Durham, North Carolina, United States, 27710-4000
Actively Recruiting
18
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
University of Cincinnati Medical Center ( Site 1035)
Cincinnati, Ohio, United States, 45219
Actively Recruiting
20
Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States, 43210
Active, Not Recruiting
21
Oregon Health & Science University ( Site 1054)
Portland, Oregon, United States, 97239
Active, Not Recruiting
22
University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
23
Rhode Island Hospital ( Site 1033)
Providence, Rhode Island, United States, 02903
Actively Recruiting
24
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina, United States, 29425
Actively Recruiting
25
University of Texas Southwestern Medical Center ( Site 1038)
Dallas, Texas, United States, 75390
Actively Recruiting
26
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston, Texas, United States, 77030
Actively Recruiting
27
Houston Methodist Hospital ( Site 1009)
Houston, Texas, United States, 77030
Actively Recruiting
28
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina, B1878GEG
Active, Not Recruiting
29
Instituto Médico Río Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina, X5800AEV
Active, Not Recruiting
30
Sanatorio Parque ( Site 1905)
Rosario, Santa Fe Province, Argentina, S2000CUB
Active, Not Recruiting
31
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario, Santa Fe Province, Argentina, S2000DSR
Active, Not Recruiting
32
Hospital Provincial del Centenario ( Site 1912)
Rosario, Santa Fe Province, Argentina, S2002KDS
Active, Not Recruiting
33
Sanatorio Allende ( Site 1908)
Córdoba, Argentina, X5021FPQ
Active, Not Recruiting
34
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe, Argentina, S3000EOZ
Active, Not Recruiting
35
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
36
The Prince Charles Hospital ( Site 1104)
Chermside, New South Wales, Australia, 4032
Actively Recruiting
37
John Hunter Hospital ( Site 1101)
New Lambton Heights, New South Wales, Australia, 2305
Active, Not Recruiting
38
Royal Hobart Hospital ( Site 1107)
Hobart, Tasmania, Australia, 7000
Actively Recruiting
39
Fiona Stanley Hospital ( Site 1103)
Murdoch, Western Australia, Australia, 6150
Active, Not Recruiting
40
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
Brussels, Bruxelles-Capitale, Region de, Belgium, 1070
Active, Not Recruiting
41
UZ Leuven ( Site 1401)
Leuven, Vlaams-Brabant, Belgium, 3000
Active, Not Recruiting
42
Hospital Dia do Pulmao ( Site 1802)
Blumenau, Santa Catarina, Brazil, 89010-000
Actively Recruiting
43
Peter Lougheed Centre ( Site 2102)
Calgary, Alberta, Canada, T1Y 6J4
Actively Recruiting
44
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
45
Fundación Neumológica Colombiana ( Site 3403)
Bogotá, Bogota D.C., Colombia, 110131
Actively Recruiting
46
Clínica Imbanaco S.A.S ( Site 3404)
Cali, Valle del Cauca Department, Colombia, 760042
Active, Not Recruiting
47
Klinicki Bolnicki Centar Split ( Site 3901)
Split, Split-Dalmatia County, Croatia, 21000
Active, Not Recruiting
48
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague, Praha 4, Czechia, 140 21
Active, Not Recruiting
49
Vseobecna fakultni nemocnice v Praze ( Site 2201)
Prague, Czechia, 128 08
Active, Not Recruiting
50
Rigshospitalet ( Site 3802)
København Ø, Capital Region, Denmark, 2100
Active, Not Recruiting
51
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus, Central Jutland, Denmark, 8200
Active, Not Recruiting
52
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice, Alpes-Maritimes, France, 06300
Actively Recruiting
53
CHU Bordeaux Haut-Leveque ( Site 1312)
Pessac, Aquitaine, France, 33604
Actively Recruiting
54
Nouvel Hôpital Civil (NHC) ( Site 1307)
Strasbourg, Bas-Rhin, France, 67000
Active, Not Recruiting
55
Hopital Cavale Blanche ( Site 1314)
Brest, Finistere, France, 29609
Actively Recruiting
56
Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne, France, 31400
Active, Not Recruiting
57
CHU de Grenoble Hopital Nord ( Site 1303)
La Tronche, Isere, France, 38700
Active, Not Recruiting
58
Hopital Nord Laennec ( Site 1309)
Saint-Herblain, Loire-Atlantique, France, 44800
Actively Recruiting
59
CHU Angers ( Site 1313)
Angers, Maine-et-Loire, France, 49100
Actively Recruiting
60
CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306)
Lille, Nord, France, 59037
Actively Recruiting
61
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
Saint-Étienne-de-Montluc, Pays de la Loire Region, France, 42055
Actively Recruiting
62
Hôpital Louis Pradel ( Site 1317)
Lyon, Rhone, France, 69677
Actively Recruiting
63
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France, 94275
Actively Recruiting
64
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers, Vienne, France, 86021
Actively Recruiting
65
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
Heidelberg, Baden-Wurttemberg, Germany, 69126
Actively Recruiting
66
Krankenhaus Neuwittelsbach ( Site 1510)
München, Bavaria, Germany, 80639
Active, Not Recruiting
67
UKGM Gießen/Marburg ( Site 1512)
Giessen, Hesse, Germany, 35392
Actively Recruiting
68
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
69
Universitaetsklinikum Koeln ( Site 1511)
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
70
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
Dresden, Saxony, Germany, 01307
Actively Recruiting
71
Universitätsklinikum Leipzig ( Site 1508)
Leipzig, Saxony, Germany, 04103
Actively Recruiting
72
Universitätsklinikum Halle ( Site 1502)
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
73
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, Germany, 14050
Active, Not Recruiting
74
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
Athens, Attica, Greece, 124 62
Active, Not Recruiting
75
Onassis Cardiac Surgery Center ( Site 3602)
Athens, Attica, Greece, 176 74
Actively Recruiting
76
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
Thessaloniki, Greece, 546 36
Active, Not Recruiting
77
Carmel Hospital ( Site 1705)
Haifa, Israel, 3436212
Actively Recruiting
78
Haddasah Medical Center ( Site 1711)
Jerusalem, Israel, 9112001
Actively Recruiting
79
Rabin Medical Center ( Site 1703)
Petah Tikva, Israel, 4941492
Active, Not Recruiting
80
Sheba Medical Center ( Site 1701)
Ramat Gan, Israel, 5265601
Active, Not Recruiting
81
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
Monza, Lombardy, Italy, 20900
Active, Not Recruiting
82
Ospedale San Giuseppe ( Site 2403)
Milan, Milano, Italy, 20123
Active, Not Recruiting
83
AOU Policlinico Umberto I ( Site 2402)
Rome, Roma, Italy, 00161
Active, Not Recruiting
84
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)
Naples, Italy, 80131
Active, Not Recruiting
85
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen, Gelderland, Netherlands, 6525 GA
Active, Not Recruiting
86
Amsterdam UMC, locatie VUmc ( Site 2601)
Amsterdam, North Holland, Netherlands, 1081 HV
Active, Not Recruiting
87
Waikato Hospital ( Site 2702)
Hamilton, Waikato Region, New Zealand, 3240
Active, Not Recruiting
88
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship, Poland, 31-202
Actively Recruiting
89
Hospital Garcia de Orta ( Site 3501)
Almada, Setúbal District, Portugal, 2805-267
Actively Recruiting
90
Hospital Pulido Valente ( Site 3503)
Lisbon, Portugal, 1769-001
Actively Recruiting
91
University Clinical Hospital Center of Serbia ( Site 2901)
Belgrade, Beograd, Serbia, 11000
Active, Not Recruiting
92
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Novi Sad, Beograd, Serbia, 21000
Active, Not Recruiting
93
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
Belgrade, Serbia, 11000
Active, Not Recruiting
94
Gachon University Gil Medical Center ( Site 3103)
Incheon, South Korea, 21565
Active, Not Recruiting
95
Severance Hospital, Yonsei University Health System ( Site 3101)
Seoul, South Korea, 03722
Active, Not Recruiting
96
Samsung Medical Center ( Site 3106)
Seoul, South Korea, 06351
Active, Not Recruiting
97
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca, Balearic Islands, Spain, 07120
Active, Not Recruiting
98
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander, Cantabria, Spain, 39008
Active, Not Recruiting
99
Hospital Universitari Vall D Hebron ( Site 1605)
Barcelona, Catalonia, Spain, 08035
Active, Not Recruiting
100
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
Majadahonda, Madrid, Spain, 28222
Active, Not Recruiting
101
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, Madrid, Comunidad de, Spain, 28041
Active, Not Recruiting
102
Hospital Clinic de Barcelona ( Site 1602)
Barcelona, Spain, 08036
Active, Not Recruiting
103
Hospital Universitario La Paz ( Site 1610)
Madrid, Spain, 28046
Active, Not Recruiting
104
Hospital General Universitario Ramon y Cajal ( Site 1609)
Madrid, Spain, 28048
Active, Not Recruiting
105
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
Toledo, Spain, 45007
Active, Not Recruiting
106
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg, Västra Götaland County, Sweden, 41346
Active, Not Recruiting
107
UniversitätsSpital Zürich ( Site 3301)
Zurich, Switzerland, 8091
Active, Not Recruiting
108
Kaohsiung Veteran General Hospital ( Site 3702)
Kaohsiung City, Taiwan, 813
Active, Not Recruiting
109
National Cheng Kung University Hospital ( Site 3703)
Tainan, Taiwan, 704302
Active, Not Recruiting
110
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
Active, Not Recruiting
111
Golden Jubilee National Hospital ( Site 1204)
Glasgow, Glasgow City, United Kingdom, G81 4DY
Active, Not Recruiting
112
Royal Free Hospital ( Site 1202)
London, London, City of, United Kingdom, NW3 2QG
Active, Not Recruiting
113
Royal Brompton Hospital ( Site 1206)
London, London, City of, United Kingdom, SW3 6NP
Active, Not Recruiting
114
Hammersmith Hospital ( Site 1203)
London, London, City of, United Kingdom, W12 0HS
Active, Not Recruiting
115
Freeman Hospital ( Site 1205)
Newcastle upon Tyne, United Kingdom, NE7 7DN
Active, Not Recruiting
116
Royal Hallamshire Hospital ( Site 1207)
Sheffield, United Kingdom, S10 2JF
Active, Not Recruiting
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Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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