Phase
Condition
Circulation Disorders
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,
ArgentinaActive - Recruiting
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes,
ArgentinaActive - Recruiting
Instituto Medico Rio Cuarto
Río Cuarto,
ArgentinaActive - Recruiting
Hospital Provincial Dr. Jose Maria Cullen
Santa Fe,
ArgentinaActive - Recruiting
St Vincent's Hospital (Melbourne)
Fitzroy,
AustraliaActive - Recruiting
Hopital Erasme
Anderlecht,
BelgiumActive - Recruiting
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
Praha,
CzechiaActive - Recruiting
Aarhus Universiteshospital
Aarhus,
DenmarkActive - Recruiting
CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
Le Kremlin-Bicêtre,
FranceActive - Recruiting
CHU de Nice - Hopital Pasteur
Nice,
FranceActive - Recruiting
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg,
GermanyActive - Recruiting
Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg,
GermanyActive - Recruiting
ATTIKON University Hospital, 2nd Critical Care Department
Athens,
GreeceActive - Recruiting
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloníki,
GreeceActive - Recruiting
Lady Davis Carmel Medical Center
Haifa,
IsraelActive - Recruiting
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
Bologna,
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia,
ItalyActive - Recruiting
A.O.U. Policlinico Umberto I
Roma,
ItalyActive - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofActive - Recruiting
Pauls Stradins Clinical University Hospital
Riga,
LatviaActive - Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas,
LithuaniaActive - Recruiting
Erasmus MC
Rotterdam,
NetherlandsActive - Recruiting
Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
Porto,
PortugalActive - Recruiting
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade,
SerbiaActive - Recruiting
National Heart Centre Singapore
Singapore,
SingaporeActive - Recruiting
National University Heart Centre
Singapore,
SingaporeActive - Recruiting
Hospital Clinic I Provincial
Barcelona,
SpainActive - Recruiting
Hospital Universitario 12 De Octubre
Madrid,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainActive - Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge,
United KingdomActive - Recruiting
Golden Jubilee National Hospital
Clydebank,
United KingdomActive - Recruiting
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California 90073
United StatesActive - Recruiting
Northside Hospital - Atlanta
Atlanta, Georgia 30342
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
Houston Methodist Outpatient Center
Houston, Texas 77030
United StatesActive - Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia 22042
United StatesActive - Recruiting
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23230
United StatesActive - Recruiting
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