Phase
Condition
Pulmonary Arterial Hypertension
Stress
Williams Syndrome
Treatment
Seralutinib
Gereic Dry Powder Inhaler
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must have completed a qualifying last visit in a prior seralutinib PAHstudy on investigational product (IP) and in accordance with the protocol.
Evidence of an informed consent document, signed and dated by the subject,indicating that the subject has been informed of all pertinent aspects of the studyprior to initiation of any subject-mandated procedures.
Willingness and ability to comply with scheduled visits, treatment plan, laboratorytests, and other study procedures
Women of childbearing potential (WOCBP) must have a negative urine or serumpregnancy test at enrollment visit before first administration of InvestigationalProduct (IP) in this study.
WOCBP who are not abstinent and intend to be sexually active with a non-sterilizedmale partner must be willing to use a highly effective method of contraception fromconsent through 30 days following the last administration of IP.
Male subjects: Non-sterilized male subjects who are not abstinent and intend to besexually active with a female partner of childbearing potential must use a malecondom from consent through 90 days after the last dose of IP.
Exclusion
Exclusion Criteria:
Severe acute or chronic medical or laboratory abnormality that may increase the riskassociated with study participation or seralutinib administration, unless associatedwith an ongoing AE and discussed with the Sponsor's medical monitor (MM) (ordesignee).
Have any other condition or reason that, in the opinion of the Investigator, wouldprohibit the subject from participating in the study.
Study Design
Study Description
Connect with a study center
Cardiologia Palermo
Buenos Aires,
ArgentinaSite Not Available
Cardiologia Palermo
Buenos Aires 3435910,
ArgentinaSite Not Available
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes,
ArgentinaSite Not Available
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes 3435217,
ArgentinaSite Not Available
Instuto de Investigacion Clinicas Quilmes
Quilmes,
ArgentinaSite Not Available
Instuto de Investigacion Clinicas Quilmes
Quilmes 3429652,
ArgentinaSite Not Available
Instituto Medico Rio Cuarto
Río Cuarto,
ArgentinaSite Not Available
Instituto Medico Rio Cuarto
Río Cuarto 3838874,
ArgentinaSite Not Available
Hospital Provincial Dr. Jose Maria Cullen
Santa Fe,
ArgentinaSite Not Available
Hospital Provincial Dr. Jose Maria Cullen
Santa Fe 3836277,
ArgentinaSite Not Available
Wesley Research Institute
Auchenflower,
AustraliaSite Not Available
Wesley Research Institute
Auchenflower 6943571,
AustraliaSite Not Available
St Vincent's Hospital (Melbourne)
Fitzroy,
AustraliaSite Not Available
St Vincent's Hospital (Melbourne)
Fitzroy 2166584,
AustraliaSite Not Available
Royal Hobart Hospital
Hobart 2163355,
AustraliaSite Not Available
Hopital Erasme
Anderlecht,
BelgiumSite Not Available
Hopital Erasme
Anderlecht 2803201,
BelgiumSite Not Available
University Hospitals of Leuven (Campus Gasthuisberg)
Leuven 2792482,
BelgiumSite Not Available
Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte 3470127,
BrazilSite Not Available
Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di Pulmao
Blumenau 3469968,
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre,
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre 3452925,
BrazilSite Not Available
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre 3452925,
BrazilSite Not Available
Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao Paulo
São Paulo 3448439,
BrazilSite Not Available
Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP
São Paulo 3448439,
BrazilSite Not Available
Peter Lougheed Center
Calgary 5913490,
CanadaSite Not Available
London Health Sciences Centre - Victoria Hospital
London 6058560,
CanadaSite Not Available
University of Ottawa Heart Institute
Ottawa 6094817,
CanadaSite Not Available
University Health Network, Toronto General Hospital
Toronto 6167865,
CanadaSite Not Available
Centro de Investigacion Clinica UC-CICUC
Santiago,
ChileSite Not Available
Enroll SpA
Santiago,
ChileActive - Recruiting
Centro de Investigacion Clinica UC-CICUC
Santiago 3871336,
ChileSite Not Available
Enroll SpA
Santiago 3871336,
ChileSite Not Available
Fundacion Abood Shaio
Bogotá 3688689,
ColombiaSite Not Available
Fundacion Neumologica Colombiana
Bogotá 3688689,
ColombiaSite Not Available
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
Prague 3067696,
CzechiaSite Not Available
Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi
Prague 3067696,
CzechiaSite Not Available
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
Praha,
CzechiaActive - Recruiting
Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi
Praha,
CzechiaSite Not Available
Aarhus Universiteshospital
Aarhus,
DenmarkSite Not Available
Aarhus Universiteshospital
Aarhus 2624652,
DenmarkSite Not Available
CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
Le Kremlin-Bicêtre,
FranceSite Not Available
CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
Le Kremlin-Bicêtre 3003737,
FranceSite Not Available
Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie
Lille,
FranceSite Not Available
Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie
Lille 2998324,
FranceSite Not Available
CHU de Nice - Hopital Pasteur
Nice,
FranceSite Not Available
CHU de Nice - Hopital Pasteur
Nice 2990440,
FranceSite Not Available
CHU de Poitiers
Poitiers,
FranceSite Not Available
CHU de Poitiers
Poitiers 2986495,
FranceSite Not Available
Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln
Cologne 2886242,
GermanySite Not Available
Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat
Dresden,
GermanySite Not Available
Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat
Dresden 2935022,
GermanySite Not Available
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
Giessen 2920512,
GermanySite Not Available
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
Gießen,
GermanySite Not Available
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg,
GermanySite Not Available
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg 2907911,
GermanySite Not Available
Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln
Köln,
GermanySite Not Available
Klinikum der LMU Medizinische Klinik und Poliklinik V
Munich 2867714,
GermanySite Not Available
Krankenhaus Neuwittelsbach
München,
GermanySite Not Available
Krankenhaus Neuwittelsbach
München 2867711,
GermanySite Not Available
Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg,
GermanySite Not Available
Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg 2805615,
GermanySite Not Available
"Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic
Athens,
GreeceSite Not Available
ATTIKON University Hospital, 2nd Critical Care Department
Athens,
GreeceActive - Recruiting
"Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic
Athens 264371,
GreeceSite Not Available
ATTIKON University Hospital, 2nd Critical Care Department
Athens 264371,
GreeceSite Not Available
Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department
Kallithea 261414,
GreeceSite Not Available
Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department
Kallithéa,
GreeceSite Not Available
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloniki 734077,
GreeceSite Not Available
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloníki,
GreeceSite Not Available
Mater Misericordiae University Hospital
Dublin 2964574,
IrelandSite Not Available
Lady Davis Carmel Medical Center
Haifa,
IsraelSite Not Available
Lady Davis Carmel Medical Center
Haifa 294801,
IsraelSite Not Available
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
Bologna,
ItalySite Not Available
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
Bologna 3181928,
ItalySite Not Available
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Napoli,
ItalySite Not Available
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Napoli 9031661,
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia,
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia 3171366,
ItalySite Not Available
A.O.U. Policlinico Umberto I
Roma,
ItalySite Not Available
A.O.U. Policlinico Umberto I
Roma 8957247,
ItalySite Not Available
University of Tokyo Hospital
Bunkyō City 11790632,
JapanSite Not Available
University of Tokyo Hospital
Bunkyō-Ku,
JapanSite Not Available
Kyushu University Hospital
Fukuoka 1863967,
JapanSite Not Available
Kyorin University Hospital
Mitaka 11790343,
JapanSite Not Available
Nagoya University Hospital
Nagoya,
JapanSite Not Available
Nagoya University Hospital
Nagoya 1856057,
JapanSite Not Available
NHO Okayama Medical Center
Okayama 1854383,
JapanSite Not Available
Keio University Hospital
Shinjuku-Ku,
JapanSite Not Available
National Cerebral and Cardiovascular Center
Suita,
JapanSite Not Available
National Cerebral and Cardiovascular Center
Suita 1851483,
JapanSite Not Available
Samsung Medical Center
Seoul,
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofActive - Recruiting
Pauls Stradins Clinical University Hospital
Riga,
LatviaSite Not Available
Pauls Stradins Clinical University Hospital
Riga 456172,
LatviaSite Not Available
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas,
LithuaniaSite Not Available
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas 598316,
LithuaniaSite Not Available
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City 3530597,
MexicoSite Not Available
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey,
MexicoSite Not Available
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey 3995465,
MexicoSite Not Available
Amsterdam UMC, location VU mc
Amsterdam 2759794,
NetherlandsSite Not Available
Erasmus MC
Rotterdam,
NetherlandsSite Not Available
Erasmus MC
Rotterdam 2747891,
NetherlandsSite Not Available
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
Krakow 3094802,
PolandSite Not Available
Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny
Otwock,
PolandSite Not Available
Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny
Otwock 762788,
PolandSite Not Available
Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente
Lisbon 2267057,
PortugalSite Not Available
Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
Porto,
PortugalSite Not Available
Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
Porto 2735943,
PortugalSite Not Available
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2
Bucharest,
RomaniaSite Not Available
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2
Bucharest 683506,
RomaniaSite Not Available
"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department
Cluj-Napoca,
RomaniaSite Not Available
"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department
Cluj-Napoca 681290,
RomaniaSite Not Available
King Fahad Medical City
Riyadh 108410,
Saudi ArabiaSite Not Available
King Faisal Specialist Hospital and Research Center
Riyadh 108410,
Saudi ArabiaSite Not Available
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade,
SerbiaSite Not Available
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade 792680,
SerbiaSite Not Available
National Heart Centre Singapore
Singapore,
SingaporeSite Not Available
National University Heart Centre
Singapore,
SingaporeActive - Recruiting
National Heart Centre Singapore
Singapore 1880252,
SingaporeSite Not Available
National University Heart Centre
Singapore 1880252,
SingaporeSite Not Available
Asan Medical Center
Seoul 1835848,
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848,
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848,
South KoreaSite Not Available
Severance Hospital, Yonsei University Health System
Seoul 1835848,
South KoreaSite Not Available
Hospital Clinic I Provincial
Barcelona,
SpainSite Not Available
Hospital Clinic I Provincial
Barcelona 3128760,
SpainSite Not Available
Hospital Universitario 12 De Octubre
Madrid,
SpainSite Not Available
Hospital Universitario 12 De Octubre
Madrid 3117735,
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander 3109718,
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla,
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Seville 2510911,
SpainSite Not Available
Hospital Universitario de Toledo
Toledo,
SpainSite Not Available
Hospital Universitario de Toledo
Toledo 2510409,
SpainSite Not Available
Royal Papworth Hospital NHS Foundation Trust
Cambridge,
United KingdomSite Not Available
Royal Papworth Hospital NHS Foundation Trust
Cambridge 2653941,
United KingdomSite Not Available
Golden Jubilee National Hospital
Clydebank,
United KingdomSite Not Available
Golden Jubilee National Hospital
Clydebank 2652730,
United KingdomSite Not Available
Hammersmith Hospital
London,
United KingdomSite Not Available
Hammersmith Hospital
London 2643743,
United KingdomSite Not Available
Royal Free Hospital, Clinical Research Facility
London 2643743,
United KingdomSite Not Available
Freeman Hospital
Newcastle 6695976,
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield 2638077,
United KingdomSite Not Available
Valley Advanced Lung Diseases Institute
Fresno, California 93720
United StatesSite Not Available
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California 90073
United StatesSite Not Available
UC Davis Health Medical Center
Sacramento, California 95817
United StatesSite Not Available
Stanford Healthcare
Stanford, California 94305
United StatesSite Not Available
Valley Advanced Lung Diseases Institute
Fresno 5350937, California 5332921 93720
United StatesSite Not Available
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles 5368361, California 5332921 90073
United StatesSite Not Available
UC Davis Health Medical Center
Sacramento 5389489, California 5332921 95817
United StatesSite Not Available
Stanford Healthcare
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
University of Florida Health
Gainesville 4156404, Florida 4155751 32610
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Northside Hospital - Atlanta
Atlanta, Georgia 30342
United StatesActive - Recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia 30309
United StatesSite Not Available
The Emory Clinic
Atlanta, Georgia 30322
United StatesActive - Recruiting
Northside Hospital - Atlanta
Atlanta 4180439, Georgia 4197000 30342
United StatesSite Not Available
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta 4180439, Georgia 4197000 30309
United StatesSite Not Available
The Emory Clinic
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
UI Health Hospital
Chicago, Illinois 60612
United StatesSite Not Available
UI Health Hospital
Chicago 4887398, Illinois 4896861 60612
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Pulmonary Specialists
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesSite Not Available
University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131
United StatesSite Not Available
University of New Mexico Health Sciences Center
Albuquerque 5454711, New Mexico 5481136 87131
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
UNC Hospitals
Chapel Hill, North Carolina 27514
United StatesSite Not Available
UNC Hospitals
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
INTEGRIS Cardiovascular Physicians
Oklahoma City 4544349, Oklahoma 4544379 73112
United StatesSite Not Available
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Temple Heart and Vascular Institute (Outpatient Clinic)
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
The Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
UPMC Presbyterian Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Medical University of South Carolina - Nexus Research Center
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Houston Methodist Outpatient Center
Houston, Texas 77030
United StatesSite Not Available
UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Houston Methodist Outpatient Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Intermountain Medical Center
Murray, Utah 84107
United StatesSite Not Available
Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
United StatesSite Not Available
University of Utah Hospital
Salt Lake City 5780993, Utah 5549030 84132
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesSite Not Available
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23230
United StatesSite Not Available
Inova Fairfax Medical Campus
Falls Church 4758390, Virginia 6254928 22042
United StatesSite Not Available
Pulmonary Associates of Richmond, Inc.
Richmond 4781708, Virginia 6254928 23230
United StatesSite Not Available

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