This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Capsule containing GB002 (seralutinib)
Generic dry powder inhaler for GB002 (seralutinib) delivery
Number of Participants With Treatment Emergent Adverse Events
Time frame: From first dose of study drug up to 80 months or availability of commercial product
Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)
Change in the distance achieved on the 6MWT (Δ6MWT)
Time frame: Baseline, up to 80 months or availability of commercial product
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University of California, Davis Medical Center
Sacramento, California, United States
Medical Corporation
Santa Barbara, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
NYU Langone Health
New York, New York, United States
New York Presbyterian Hospital - Weill Cornell Medicine
New York, New York, United States
...and 18 more locations