This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
Type of Subject and Disease Characteristics
1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit.
2. Treatment with standard of care PAH disease-specific background therapies (stable dose).
Informed Consent
3. Review and signature of an IRB-approved informed consent form.
Exclusion Criteria:
Medical Conditions
1. Persistent and clinically significant systemic hypertension or hypotension.
2. Interval history of newly developed left-sided heart disease.
3. Potentially life-threatening cardiac arrhythmia with an ongoing risk.
4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
5. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
7. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.
8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[PCP\]).
10. Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study.
Diagnostic Assessments
11. Chronic renal insufficiency
12. Hemoglobin (Hgb) concentration \<8.5 g/dL.
13. Absolute neutrophil count (ANC) \< 1x 10\^9/L.
14. Platelet count \<50 x 10\^9/L.
Prior Therapy
15. Use of inhaled prostanoids.
16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \[NOAC\]/direct oral anticoagulant \[DOAC\]).
17. Chronic use of any prohibited medication.
NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Primary outcome measure(s)
Number of Participants With Treatment Emergent Adverse Events — From first dose of study drug up to 80 months or availability of commercial product
Trial sites (28)
Facility
City
Region
Status
University of California, Davis Medical Center
Sacramento
California
Medical Corporation
Santa Barbara
California
Mayo Clinic
Jacksonville
Florida
Cleveland Clinic Florida
Weston
Florida
University of Kansas Medical Center
Kansas City
Kansas
Norton Pulmonary Specialists
Louisville
Kentucky
Tufts Medical Center
Boston
Massachusetts
University of Nebraska Medical Center
Omaha
Nebraska
NYU Langone Health
New York
New York
New York Presbyterian Hospital - Weill Cornell Medicine
New York
New York
University of Rochester Medical Center
Rochester
New York
The Ohio State University Wexner Medical Center
Columbus
Ohio
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City
Oklahoma
Houston Methodist Hospital
Houston
Texas
University of Utah Health
Salt Lake City
Utah
Royal Hobart Hospital
Hobart
Tasmania
St. Vincent's Hospital Melbourne
Fitzroy
Victoria
Všeobecná fakultní nemocnice v Praze
Prague
Czechia
AP-HP Hôpital de Bicêtre
Le Kremlin-Bicêtre
France
DRK Kliniken Berlin
Berlin
Germany
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
Giessen
Germany
Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
Hanover
Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg
Germany
Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
Regensburg
Germany
Hospital Universitario 12 de Octubre
Madrid
Spain
Hospital Universitario Marqués de Valdecilla
Santander
Spain
Royal Papworth Hospital NHS Foundation Trust
Cambridge
United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
London
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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