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NCT04796337CompletedPhase 3

A Long-term Follow-up Study of Sotatercept for PAH Treatment

An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-004)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
420 (actual)
First submitted
26 Aug 2024
Start date
26 Aug 2021
Lead sponsor
Acceleron Pharma Inc.
NCT number
NCT04796337
EU CT number
2023-509138-21-00
EudraCT number
2020-005061-13

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 420
  • 66 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other

  • Did not participate in a sotatercept PAH parent trial. 2. Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. 3. 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. 4. Pregnant or breastfeeding females.

Who the study is looking for

  • Participants must have completed their current respective PAH sotatercept clinical study, must have completed the parent study requirements, and must not have discontinued early. 2. Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements. 3. Participants must have the ability to understand and provide documented consent 4. Females of childbearing potential must: a. Have a negative pregnancy tests 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. b. 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. c. 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. 5. Male participants must: a. 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 b. 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. 6. Participants must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the A011-12 study, except for MK-7962-038 study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (66)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ordensklinikum Linz GmbH
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LinzAustriaCompleted
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
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ViennaAustriaCompleted
Hopital Erasme
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AnderlechtBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
Institute for Clinical and Experimental Medicine
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PragueCzechiaCompleted
DRK Kliniken Berlin
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BerlinGermanyCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Koeln AöR
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CologneGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyCompleted
Justus-Liebig-Universitaet Giessen
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GiessenGermanyCompleted
Universitaetsklinikum Halle (Saale) AöR
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Halle SaaleGermanyCompleted
Medizinische Hochschule Hannover
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HanoverGermanyCompleted
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
Universitaetsklinikum des Saarlandes AöR
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HomburgGermanyCompleted
Universitaet Leipzig
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LeipzigGermanyCompleted
Krankenhaus Neuwittelsbach
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MünchenGermanyCompleted
Krankenhaus Neuwittelsbach
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MunichGermanyActive, not recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Region Midtjylland
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
University Hospital Son Espases
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PalmaSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Hospital Universitario de Toledo
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ToledoSpainCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceCompleted
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Les Hopitaux Universitaires de Strasbourg
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StrasbourgFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceActive, not recruiting
Onassis Cardiac Surgery Center
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KallitheaGreeceCompleted
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceCompleted
KBC Split
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SplitCroatiaCompleted
Multimedica S.p.A.
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MilanItalyCompleted
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyCompleted
Azienda Ospedaliera dei Colli
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NaplesItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
VUMC Stichting
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AmsterdamNetherlandsCompleted
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandCompleted
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
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OtwockPolandCompleted
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalCompleted
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenCompleted

This page is information, not medical advice. Discuss any trial with your doctor.