Phase
Condition
Vascular Diseases
Stress
Pulmonary Arterial Hypertension
Treatment
Generic Dry Powder Inhaler
GB002 (seralutinib)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type of Subject and Disease Characteristics
Subjects must have completed a prior GB002 PAH study and, in the opinion of theInvestigator and Sponsor, have been compliant with study procedures and havecompleted treatment with IP through parent study end-of-treatment (EOT) visit.
Treatment with standard of care PAH disease-specific background therapies (stabledose). Informed Consent
Review and signature of an IRB-approved informed consent form.
Exclusion
Exclusion Criteria:
Medical Conditions
Persistent and clinically significant systemic hypertension or hypotension.
Interval history of newly developed left-sided heart disease.
Potentially life-threatening cardiac arrhythmia with an ongoing risk.
Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
Other severe acute or chronic medical or laboratory abnormality that may increasethe risk associated with study participation or GB002 administration or mayinterfere with the interpretation of study results and, in the judgment of theInvestigator, would make the subject inappropriate for entry into this study.
History of portopulmonary hypertension or portal hypertension due to cirrhosisclassified as Child-Pugh Class A or higher.
Subjects with a history of severe milk protein allergy. In addition, subjects withknown intolerance or hypersensitivity to lactose who, in the opinion of theinvestigator, may experience severe symptoms following the ingestion of lactose.
Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topicalmarijuana is allowed, per local restrictions and regulations.
Current alcohol use disorder as defined by DSM-5, and/or history of currentutilization of drugs of abuse (amphetamines, methamphetamines, cocaine,phencyclidine [PCP]).
Have any other condition or reason that, in the opinion of the Investigator and/orthe Sponsor's Medical Monitor (or designee), would prohibit the subject fromparticipating in the study. Diagnostic Assessments
Chronic renal insufficiency
Hemoglobin (Hgb) concentration <8.5 g/dL.
Absolute neutrophil count (ANC) < 1x 10^9/L.
Platelet count <50 x 10^9/L. Prior Therapy
Use of inhaled prostanoids.
Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin ornovel oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
Chronic use of any prohibited medication.
NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Study Design
Connect with a study center
St Vincent's Hospital, Heart & Lung Transplant Unit
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Royal Hobart Hospital
Hobart, Tasmania 7000
AustraliaSite Not Available
St. Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaSite Not Available
University Hospital of Leuven
Leuven,
BelgiumSite Not Available
Všeobecná fakultní nemocnice v Praze
Praha, 128 08
CzechiaSite Not Available
AP-HP Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94270
FranceSite Not Available
DRK Kliniken Berlin
Berlin,
GermanySite Not Available
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
Gießen,
GermanySite Not Available
Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
Hannover, 30625
GermanySite Not Available
Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126
GermanySite Not Available
Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
Regensburg, 93053
GermanySite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario Marqués de Valdecilla
Santander, 39008
SpainSite Not Available
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 OAY
United KingdomSite Not Available
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
London,
United KingdomSite Not Available
Dept. of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California 90073
United StatesSite Not Available
University of California, Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Medical Corporation
Santa Barbara, California 93105
United StatesSite Not Available
Stanford Health Care
Stanford, California 94305
United StatesSite Not Available
Lundquist Institute for Biomedical Innovation at Harbor UCLA
Torrance, California 90502
United StatesSite Not Available
Mayo Clinic
Jacksonville, Florida 32224
United StatesSite Not Available
Cleveland Clinic Florida
Weston, Florida 33331
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesSite Not Available
Tufts Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesSite Not Available
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York 10065
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
Houston Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
University of Utah Health
Salt Lake City, Utah 84132
United StatesSite Not Available
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