Clinical trial • Phase III • Cardiology
SOTATERCEPT for Pulmonary arterial hypertension
Phase III trial of SOTATERCEPT for Pulmonary arterial hypertension. open-label, none/not specified-controlled. 418 participants.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Pulmonary arterial hypertension
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 26-08-2024
- First CTIS Authorization Date
- 24-09-2024
Trial design
open-label, none/not specified-controlled Phase III trial in Belgium, Sweden, Greece and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 418
- Trial Duration For Participant
- 1825
Eligibility
Recruits 418 Vulnerable populations selected. Country-specific informed consent documents include Newborn ICFs, Pregnant Partner ICFs and other special ICFs (optional photography, self-administration). Documented informed consent is required from participants; specific ICFs for newborns and pregnant partners are provided (multiple language/country versions available)..
- Pregnancy Exclusion
- Pregnant or breastfeeding females.
- Vulnerable Population
- Vulnerable populations selected. Country-specific informed consent documents include Newborn ICFs, Pregnant Partner ICFs and other special ICFs (optional photography, self-administration). Documented informed consent is required from participants; specific ICFs for newborns and pregnant partners are provided (multiple language/country versions available).
Inclusion criteria
- {"criterion_text":"- Participants must have completed their current respective PAH sotatercept clinical study, must have completed the parent study requirements, and must not have discontinued early.\n- Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.\n- Participants must have the ability to understand and provide documented consent\n- 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.\n- 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.\n- 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."}
Exclusion criteria
- {"criterion_text":"- Did not participate in a sotatercept PAH parent trial.\n- Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.\n- 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.\n- Pregnant or breastfeeding females."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Adverse events (AEs)\n- Anti-drug antibodies (ADA)\n- Clinical laboratory assessments (hematology)\n- Vital signs\n- 12-lead electrocardiogram (ECG)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 6-minute walk distance (6MWD)\n- N-terminal pro-hormone B-type natriuretic peptide\n- World Health Organization (WHO) functional class\n- Pulmonary vascular resistance\n- Simplified French Risk score","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 418
- Recruitment Window Months
- 58
- Consent Approach
- Documented informed consent is required from participants. Multiple subject information and informed consent forms (ICFs) are provided (main ICF, newborn ICF, pregnant partner ICF, optional photography ICF, self-administration ICF, GDPR/data consent documents and country-specific versions). ICFs are available in multiple languages (examples in the public documents: English, Dutch, French, German, Spanish, Portuguese, Czech, Polish, Swedish, Italian, Greek). Newborn and pregnant-partner specific ICFs are provided for vulnerable-subject situations.
Geography
- Total Number Of Sites
- 58
- Total Number Of Participants
- 418
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 26-09-2024
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- UZ Leuven
- Department Name
- Department of Pneumology and Respiratory Oncology
- Principal Investigator Name
- Marion Delcroix
- Principal Investigator Email
- marion.delcroix@uzleuven.be
- Contact Person Name
- Marion Delcroix
- Contact Person Email
- marion.delcroix@uzleuven.be
- Site Name
- Hopital Erasme
- Department Name
- Pulmonary Hypertension
- Principal Investigator Name
- Jean-Luc Vachiery
- Principal Investigator Email
- jeanluc.vachiery@erasme.ulb.ac.be
- Contact Person Name
- Jean-Luc Vachiery
- Contact Person Email
- jeanluc.vachiery@erasme.ulb.ac.be
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Kardiologens forskningsenhet
- Principal Investigator Name
- Clara Hjalmarsson
- Principal Investigator Email
- clara.hjalmarsson@vgregion.se
- Contact Person Name
- Clara Hjalmarsson
- Contact Person Email
- clara.hjalmarsson@vgregion.se
Greece
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 11-10-2024
- Processing Time Days
- 29
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Onassis Cardiac Surgery Center
- Department Name
- Cardiology Division
- Principal Investigator Name
- Dimitrios Tsiapras
- Principal Investigator Email
- dtsiapras@hotmail.com
- Contact Person Name
- Dimitrios Tsiapras
- Contact Person Email
- dtsiapras@hotmail.com
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- A’ Cardiology Clinic
- Principal Investigator Name
- Georgios Giannakoulas
- Principal Investigator Email
- g.giannakoulas@gmail.com
- Contact Person Name
- Georgios Giannakoulas
- Contact Person Email
- g.giannakoulas@gmail.com
- Site Name
- University General Hospital Attikon
- Department Name
- B’ University Clinic of Intensive Care
- Principal Investigator Name
- Iraklis Tsagkaris
- Principal Investigator Email
- itsagkaris@med.uoa.gr
- Contact Person Name
- Iraklis Tsagkaris
- Contact Person Email
- itsagkaris@med.uoa.gr
Czechia
- Earliest CTIS Part Ii Submission Date
- 27-09-2024
- Latest Decision Or Authorization Date
- 21-11-2024
- Processing Time Days
- 55
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Klinika kardiologie
- Principal Investigator Name
- Hikmet Al-Hiti
- Principal Investigator Email
- hial@medicon.cz
- Contact Person Name
- Hikmet Al-Hiti
- Contact Person Email
- hial@medicon.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- II. interní klinika kardiologie a angiologie
- Principal Investigator Name
- Pavel Jansa
- Principal Investigator Email
- pavel.jansa@vfn.cz
- Contact Person Name
- Pavel Jansa
- Contact Person Email
- pavel.jansa@vfn.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 08-10-2024
- Processing Time Days
- 26
- Number Of Sites
- 9
- Number Of Participants
- 47
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Pneumology
- Principal Investigator Name
- Javier Segovia Cubero
- Principal Investigator Email
- jsecu@telefonica.net
- Contact Person Name
- Javier Segovia Cubero
- Contact Person Email
- jsecu@telefonica.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Cardiology
- Principal Investigator Name
- María Pilar Escribano Subias
- Principal Investigator Email
- pilar.escribano.subias@gmail.com
- Contact Person Name
- María Pilar Escribano Subias
- Contact Person Email
- pilar.escribano.subias@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pneumology
- Principal Investigator Name
- Cristina Berastegui
- Principal Investigator Email
- cristina.berastegui@vallhebron.cat
- Contact Person Name
- Cristina Berastegui
- Contact Person Email
- cristina.berastegui@vallhebron.cat
- Site Name
- University Hospital Son Espases
- Department Name
- Neumology
- Principal Investigator Name
- Ernest Sala Llinas
- Principal Investigator Email
- ernest.sala@ssib.es
- Contact Person Name
- Ernest Sala Llinas
- Contact Person Email
- ernest.sala@ssib.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cardiology
- Principal Investigator Name
- María Jesús Del Cerro Marin
- Principal Investigator Email
- majecerro@yahoo.es
- Contact Person Name
- María Jesús Del Cerro Marin
- Contact Person Email
- majecerro@yahoo.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Principal Investigator Name
- José Manuel Cifrián Martínez
- Principal Investigator Email
- josemanuel.cifrian@scsalud.es
- Contact Person Name
- José Manuel Cifrián Martínez
- Contact Person Email
- josemanuel.cifrian@scsalud.es
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Cardiology
- Principal Investigator Name
- María Lázaro Salvador
- Principal Investigator Email
- maria.lasal@gmail.com
- Contact Person Name
- María Lázaro Salvador
- Contact Person Email
- maria.lasal@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pneumology
- Principal Investigator Name
- Sergio Alcolea Batres
- Principal Investigator Email
- alcobatres@yahoo.es
- Contact Person Name
- Sergio Alcolea Batres
- Contact Person Email
- alcobatres@yahoo.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Pneumology
- Principal Investigator Name
- Isabel Blanco
- Principal Investigator Email
- iblanco2@clinic.cat
- Contact Person Name
- Isabel Blanco
- Contact Person Email
- iblanco2@clinic.cat
France
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 26-09-2024
- Processing Time Days
- 14
- Number Of Sites
- 14
- Number Of Participants
- 80
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Service de médecine interne et pneumologie
- Principal Investigator Name
- Cécile TROMEUR
- Principal Investigator Email
- cecile.tromeur@chu-brest.fr
- Contact Person Name
- Cécile TROMEUR
- Contact Person Email
- cecile.tromeur@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service de Médecine Vasculaire
- Principal Investigator Name
- Etienne-Marie JUTANT
- Principal Investigator Email
- etienne-marie.jutant@chu-poitiers.fr
- Contact Person Name
- Etienne-Marie JUTANT
- Contact Person Email
- etienne-marie.jutant@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Service de Médecine Vasculaire et Thérapeutique
- Principal Investigator Name
- Laurent BERTOLETTI
- Principal Investigator Email
- laurent.bertoletti@gmail.com
- Contact Person Name
- Laurent BERTOLETTI
- Contact Person Email
- laurent.bertoletti@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service de Cardiologie au 1er étage
- Principal Investigator Name
- Delphine BAUDOUY
- Principal Investigator Email
- baudouy.d@chu-nice.fr
- Contact Person Name
- Delphine BAUDOUY
- Contact Person Email
- baudouy.d@chu-nice.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pneumologie
- Principal Investigator Name
- Vincent COTTIN
- Principal Investigator Email
- vincent.cottin@chu-lyon.fr
- Contact Person Name
- Vincent COTTIN
- Contact Person Email
- vincent.cottin@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service de Médecine Vasculaire
- Principal Investigator Name
- Arnaud BOURDIN
- Principal Investigator Email
- a-bourdin@chu-montpellier.fr
- Contact Person Name
- Arnaud BOURDIN
- Contact Person Email
- a-bourdin@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- François PICARD
- Principal Investigator Email
- francois.picard@chu-bordeaux.fr
- Contact Person Name
- François PICARD
- Contact Person Email
- francois.picard@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Département de Pneumologie
- Principal Investigator Name
- Frédéric GAGNADOUX
- Principal Investigator Email
- frgagnadoux@chu-angers.fr
- Contact Person Name
- Frédéric GAGNADOUX
- Contact Person Email
- frgagnadoux@chu-angers.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de pneumologie
- Principal Investigator Name
- Marianne RIOU
- Principal Investigator Email
- marianne.riou@chru-strasbourg.fr
- Contact Person Name
- Marianne RIOU
- Contact Person Email
- marianne.riou@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Pascal De Groote
- Principal Investigator Email
- pascal.degroote@chru-lille.fr
- Contact Person Name
- Pascal De Groote
- Contact Person Email
- pascal.degroote@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Service des maladies respiratoires
- Principal Investigator Name
- Bruno DEGANO
- Principal Investigator Email
- bdegano@chu-grenoble.fr
- Contact Person Name
- Bruno DEGANO
- Contact Person Email
- bdegano@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Delphine HOREAU-LANGLARD
- Principal Investigator Email
- delphine.horeaulanglard@chu-nantes.fr
- Contact Person Name
- Delphine HOREAU-LANGLARD
- Contact Person Email
- delphine.horeaulanglard@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de Pneumologie et Réanimation Respiratoire
- Principal Investigator Name
- David MONTANI
- Principal Investigator Email
- david.montani@aphp.fr
- Contact Person Name
- David MONTANI
- Contact Person Email
- david.montani@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Grégoire PREVOT
- Principal Investigator Email
- prevot.g@chu-toulouse.fr
- Contact Person Name
- Grégoire PREVOT
- Contact Person Email
- prevot.g@chu-toulouse.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 07-10-2024
- Processing Time Days
- 25
- Number Of Sites
- 11
- Number Of Participants
- 149
Sites
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin II
- Principal Investigator Name
- Stefan Stadler
- Principal Investigator Email
- stefan.stadler@ukr.de
- Contact Person Name
- Stefan Stadler
- Contact Person Email
- stefan.stadler@ukr.de
- Site Name
- Krankenhaus Neuwittelsbach
- Department Name
- 2. Medizinische Abteilung
- Principal Investigator Name
- Hanno Leuchte
- Principal Investigator Email
- Prof.Leuchte@krankenhaus-neuwittelsbach.de
- Contact Person Name
- Hanno Leuchte
- Contact Person Email
- Prof.Leuchte@krankenhaus-neuwittelsbach.de
- Site Name
- Universitaet Leipzig
- Department Name
- Medizinische Klinik II, Bereich II Pneumologie
- Principal Investigator Name
- Hubert Wirtz
- Principal Investigator Email
- hubert.wirtz@medizin.uni-leipzig.de
- Contact Person Name
- Hubert Wirtz
- Contact Person Email
- hubert.wirtz@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Halle (Saale) AöR
- Department Name
- Universitätsklinik und Poliklinik für Innere Medizin I
- Principal Investigator Name
- Stephan Eisenmann
- Principal Investigator Email
- stephan.eisenmann@uk-halle.de
- Contact Person Name
- Stephan Eisenmann
- Contact Person Email
- stephan.eisenmann@uk-halle.de
- Site Name
- DRK Kliniken Berlin
- Department Name
- Studienbüro / Kardiologie
- Principal Investigator Name
- Christian Opitz
- Principal Investigator Email
- c.opitz@drk-kliniken-berlin.de
- Contact Person Name
- Christian Opitz
- Contact Person Email
- c.opitz@drk-kliniken-berlin.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Zentrum für Pulmonale Hypertonie
- Principal Investigator Name
- Ekkehard Grünig
- Principal Investigator Email
- ekkehard.gruenig@med.uni-heidelberg.de
- Contact Person Name
- Ekkehard Grünig
- Contact Person Email
- ekkehard.gruenig@med.uni-heidelberg.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Medizinische Klinik I
- Principal Investigator Name
- Michael Halank
- Principal Investigator Email
- michael.halank@uniklinikum-dresden.de
- Contact Person Name
- Michael Halank
- Contact Person Email
- michael.halank@uniklinikum-dresden.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik III für Innere Medizin
- Principal Investigator Name
- Stephan Rosenkranz
- Principal Investigator Email
- stephan.rosenkranz@uk-koeln.de
- Contact Person Name
- Stephan Rosenkranz
- Contact Person Email
- stephan.rosenkranz@uk-koeln.de
- Site Name
- Universitaetsklinikum des Saarlandes AöR
- Department Name
- Innere Medizin V
- Principal Investigator Name
- Heinrike Wilkens
- Principal Investigator Email
- Heinrike.Wilkens@uks.eu
- Contact Person Name
- Heinrike Wilkens
- Contact Person Email
- Heinrike.Wilkens@uks.eu
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Ardeschir Ghofrani
- Principal Investigator Email
- Ardeschir.Ghofrani@innere.med.uni-giessen.de
- Contact Person Name
- Ardeschir Ghofrani
- Contact Person Email
- Ardeschir.Ghofrani@innere.med.uni-giessen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Abteilung Pneumologie
- Principal Investigator Name
- Marius Hoeper
- Principal Investigator Email
- hoeper.marius@mh-hannover.de
- Contact Person Name
- Marius Hoeper
- Contact Person Email
- hoeper.marius@mh-hannover.de
Croatia
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 13
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- KBC Split
- Department Name
- Clinic for pulmonary diseases
- Principal Investigator Name
- Mislav Lozo
- Principal Investigator Email
- mislav.lozo@gmail.com
- Contact Person Name
- Mislav Lozo
- Contact Person Email
- mislav.lozo@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 24-09-2024
- Latest Decision Or Authorization Date
- 24-09-2024
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Rheumatology
- Principal Investigator Name
- Madelon Vonk
- Principal Investigator Email
- madelon.vonk@radboudumc.nl
- Contact Person Name
- Madelon Vonk
- Contact Person Email
- madelon.vonk@radboudumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmonary Department
- Principal Investigator Name
- Karin Boomars
- Principal Investigator Email
- k.boomars@erasmusmc.nl
- Contact Person Name
- Karin Boomars
- Contact Person Email
- k.boomars@erasmusmc.nl
- Site Name
- VUMC Stichting
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- Anton Anton Vonk Noordegraaf
- Principal Investigator Email
- a.vonk@amsterdamumc.nl
- Contact Person Name
- Anton Anton Vonk Noordegraaf
- Contact Person Email
- a.vonk@amsterdamumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 25-09-2024
- Processing Time Days
- 13
- Number Of Sites
- 2
- Number Of Participants
- 35
Sites
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Name
- Grzegorz Kopec
- Principal Investigator Email
- sekr_kard@szpitaljp2.krakow.pl
- Contact Person Name
- Grzegorz Kopec
- Contact Person Email
- sekr_kard@szpitaljp2.krakow.pl
- Site Name
- Europejskie Centrum Zdrowia Otwock Sp. z o.o.
- Department Name
- Szpital im. Fryderyka Chopina Oddzial Kardiologii
- Principal Investigator Name
- Marcin Kurzyna
- Principal Investigator Email
- marcin.kurzyna@ecz-otwock.pl
- Contact Person Name
- Marcin Kurzyna
- Contact Person Email
- marcin.kurzyna@ecz-otwock.pl
Denmark
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Søren Mellemkjær
- Principal Investigator Email
- soren.mellemkjaer@rm.dk
- Contact Person Name
- Søren Mellemkjær
- Contact Person Email
- soren.mellemkjaer@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Mads Ersbøll
- Principal Investigator Email
- mads.kristian.ersboell.02@regionh.dk
- Contact Person Name
- Mads Ersbøll
- Contact Person Email
- mads.kristian.ersboell.02@regionh.dk
Portugal
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 15
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Serviço Cardiologia
- Principal Investigator Name
- Sofia Alegria
- Principal Investigator Email
- filipa.ferreira@ulsas.min-saude.pt
- Contact Person Name
- Sofia Alegria
- Contact Person Email
- filipa.ferreira@ulsas.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Serviço Cardiologia
- Principal Investigator Name
- Rui Plácido
- Principal Investigator Email
- placidorui@gmail.com
- Contact Person Name
- Rui Plácido
- Contact Person Email
- placidorui@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 09-10-2024
- Processing Time Days
- 27
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- DAI Cardio-Toraco-Vascolare e Chirurgia dei Trapianti d’Organo
- Principal Investigator Name
- Carmine Dario Vizza
- Principal Investigator Email
- dario.vizza@uniroma1.it
- Contact Person Name
- Carmine Dario Vizza
- Contact Person Email
- dario.vizza@uniroma1.it
- Site Name
- Multimedica S.p.A.
- Department Name
- U.O. Pneumologia e Terapia Semintensiva Respiratoria
- Principal Investigator Name
- Sergio Harari
- Principal Investigator Email
- sergioalfonso.harari@multimedica.it
- Contact Person Name
- Sergio Harari
- Contact Person Email
- sergioalfonso.harari@multimedica.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- S.C. Pneumologia
- Principal Investigator Name
- Giuseppe Paciocco
- Principal Investigator Email
- giuseppe.paciocco@unimib.it
- Contact Person Name
- Giuseppe Paciocco
- Contact Person Email
- giuseppe.paciocco@unimib.it
- Site Name
- Azienda Ospedaliera Dei Colli
- Department Name
- U.O.C. Cardiologia
- Principal Investigator Name
- Michele D'Alto
- Principal Investigator Email
- ipertensionepolmonare@ospedalideicolli.it
- Contact Person Name
- Michele D'Alto
- Contact Person Email
- ipertensionepolmonare@ospedalideicolli.it
Austria
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 12-11-2024
- Processing Time Days
- 61
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
- Department Name
- Universitätsklinik für Innere Medizin II - Kardiologie
- Principal Investigator Name
- Irene Marthe Lang
- Principal Investigator Email
- irene.lang@meduniwien.ac.at
- Contact Person Name
- Irene Marthe Lang
- Contact Person Email
- irene.lang@meduniwien.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Interne 2 - Kardiologie, Angiologie & Interne Intensivmedizin
- Principal Investigator Name
- Regina Steringer-Mascherbauer
- Principal Investigator Email
- regina.steringer-mascherbauer@ordensklinikum.at
- Contact Person Name
- Regina Steringer-Mascherbauer
- Contact Person Email
- regina.steringer-mascherbauer@ordensklinikum.at
Sponsor
Primary sponsor
- Full Name
- Acceleron Pharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research LLC
- Responsibilities
- ECG/ECHO imaging
- Name
- PPD Development LP
- Responsibilities
- multiple operational roles (codes listed in sponsor record)
- Name
- PPD Global Ltd.
- Responsibilities
- central lab and local operational roles (codes present in record)
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sample/services (code 3)
- Name
- QPS LLC
- Responsibilities
- PK, ADA Samples
Third parties
- {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"ECG/ECHO imaging","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"eCOA","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: [1,11,12,2,4,5,6,7,8]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Gray Consulting Inc.","duties_or_roles":"Patient Travel Expenses","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eDC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes: [1,12]","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Patient Travel & Reimbursement (France)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"storage/packaging/labeling (code 3)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"PK, ADA Samples","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient Education, Engagement, Patient Facing Newsletters","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"PPD Development LP (additional address)","duties_or_roles":"BioMarker Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Sample management (MCP-1, IL-6), Supplies services, Logistics services; code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- sotatercept
- Active Substance
- SOTATERCEPT
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- SUBCUTANEOUS
- Authorisation Status
- Investigational product (MIA number IMP11011/00003) / Biological
- Orphan Designation
- Yes
- Frequency
- Every 21 days (±3 days)
- Maximum Dose
- Max total dose amount 105 mg (as listed); max daily dose amount 0.7 mg/Kg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- SOTATERCEPT for Pulmonary arterial hypertension
- CALCIFEDIOL for Pulmonary arterial hypertension
- Activin signaling inhibitor (specific active substance not stated) for Pulmonary arterial hypertension
- PF-07868489 for Pulmonary arterial hypertension
- (S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Pulmonary arterial hypertension