Phase
Condition
Pulmonary Arterial Hypertension
Williams Syndrome
Stress
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 have completedtreatment 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 increase therisk associated with study participation or GB002 administration or may interfere withthe interpretation of study results and, in the judgment of the Investigator, wouldmake 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/or theSponsor's Medical Monitor (or designee), would prohibit the subject from participatingin 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 or noveloral 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
AustraliaActive - Recruiting
Royal Hobart Hospital
Hobart, Tasmania 7000
AustraliaActive - Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
University Hospital of Leuven
Leuven,
BelgiumActive - Recruiting
Všeobecná fakultní nemocnice v Praze
Praha, 128 08
CzechiaActive - Recruiting
AP-HP Hôpital de Bicêtre
Le Kremlin-Bicêtre, 94270
FranceActive - Recruiting
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
Gießen,
GermanyActive - Recruiting
Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
Hannover, 30625
GermanyActive - Recruiting
Thoraxklinik-Heidelberg gGmbH
Heidelberg, 69126
GermanyActive - Recruiting
Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
Regensburg, 93053
GermanyActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
SpainActive - Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 OAY
United KingdomActive - Recruiting
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
London,
United KingdomActive - Recruiting
Dept. of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California 90073
United StatesActive - Recruiting
University of California, Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
Medical Corporation
Santa Barbara, California 93105
United StatesActive - Recruiting
Stanford Health Care
Stanford, California 94305
United StatesActive - Recruiting
Lundquist Institute for Biomedical Innovation at Harbor UCLA
Torrance, California 90502
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Norton Pulmonary Specialists
Louisville, Kentucky 40202
United StatesActive - Recruiting
Tufts Medical Center
Boston, Massachusetts 02111
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York 10065
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14642
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
University of Utah Health
Salt Lake City, Utah 84132
United StatesActive - Recruiting
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