Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Phase 3 – large-scale trial before approval
Conditions:
Pulmonary Arterial Hypertension
Sponsor: GB002, Inc.
trial.available_in:
БГ
Overview
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
Description
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Who can participate
Inclusion Criteria:
1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
2. 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 study prior to initiation of any subject-mandated procedures.
3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.
Exclusion Criteria:
1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
Locations
28
Argentina (1)
Cardiologia Palermo
Buenos Aires
Australia (1)
Wesley Research Institute
Auchenflower
Belgium (1)
University Hospitals of Leuven (Campus Gasthuisberg)
Leuven
Brazil (1)
Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte
Canada (1)
Peter Lougheed Center
Calgary
Chile (1)
Centro de Investigacion Clinica UC-CICUC
Santiago
Colombia (1)
Fundacion Abood Shaio
Bogotá
Czech Republic (1)
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
Prague
Denmark (1)
Aarhus Universiteshospital
Aarhus
France (1)
CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
Le Kremlin-Bicêtre
Greece (1)
"Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic
Athens
Ireland (1)
Mater Misericordiae University Hospital
Dublin
Israel (1)
Lady Davis Carmel Medical Center
Haifa
Italy (1)
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
Bologna
Japan (1)
University of Tokyo Hospital
Bunkyō City
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
Mexico (1)
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City
Netherlands (1)
Amsterdam UMC, location VU mc
Amsterdam
Poland (1)
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
Krakow
Romania (1)
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2
Bucharest
Saudi Arabia (1)
King Fahad Medical City
Riyadh
Serbia (1)
University Clinical Centre of Serbia, Cardiology Clinic