Gb002 In Adult Subjects With Pah
Posted Date: Sep 8, 2020
- Investigator: Jean Elwing
- Type of Study: Drug
This is a phase 2, randomized, double-blind, placebo-controlled clinical trial with the purpose of evaluating the efficacy and safety of GBoo2 in adult subjects diagnosed with WHO Group 1 pulmonary artery hypertension(PAH).
Subjects Must Meet All Of The Following Criteria To Be Eligible To Participate In This Study. All Participants Must Be Able To And Willing To Sign And Date The Inform Consent Form Prior To Any Study-Specific Procedures Being Performed. Subjects Must Be Female Between The Ages Of 18 To 80 Or Male Between The Ages Of 50 To 80 With A Diagnosis Of Who Group 1 Pah, Who Fc Ii Or Iii, On Stable Pah Therapy And Able To Complete A 6-Minute Walk Distance Between 150 To 550 Meters At Screening. He Or She Must Meet The Following Hemodynamic Criteria At Screening: Mpap >/= 25Mmhg, Pawp Or Lvedp = 15Mmhg, And Pvr >/= 400 Dynes/Cm5. At Screening, He Or She Must Also Meet The Following Criteria For The Pulmonary Function Test (Pft) And Diffusing Capacity Of The Lungs For Carbon Monoxide (Dlco): Forced Expiratory Volume In 1 Second >/= 60% And Dlco >/= 40% Except For Subjects With Pah Due To Systemic Sclerosis In Which Case A Dlco >/= 30% Is Permitted. Subjects Must Use An Acceptable Method Of Contraception Throughout The Study. Participants Will Be Excluded From The Study If They Have Any Of The Following Medical Conditions: An Acute Pulmonary Embolism Or Chronic Thromboembolic Disease Assessed Prior To Or At Screening, Uncontrolled Hypertension, Systolic Blood Pressure < 90 Mmhg During Screening And Baseline Visits, Who Group 2-5, Hiv Associated Pah, History Of Left-Sided Heart Disease, Clinically Significant Cardiac, Hepatic, Or Renal Disease As Noted Per Protocol, Untreated Obstructive Sleep Apnea, History Of Atrial Septostomy Within 180 Days Of Screening, Pulmonary Venous Occlusive Disease, Significant Liver Impairment, History Of Malignancy, An Active Infection Requiring Systemic Therapy, Significant Lab Abnormality That May Increase The Subject’S Risk For Participation, Any Disease That May Limit The 6Mwt Evaluation, Pregnant, Lactating Or Planning To Become Pregnant. Subjects Will Be Exempt If Their Body Weight Is < 40 Kg At Screening, Hemoglobin Is < 8.5 G/Dl At Screening, There Is Evidence Of Having Active Human Immunodeficiency Virus, Hepatitis B Or C, Or Tuberculosis At Screening. Subjects On Inhaled Prostanoids, Anticoagulants Or Require Intravenous Inotrope Therapy Within 4 Weeks Of Screening, Will Not Be Eligible To Participate In The Study. Prior Experience With Gb002 Studies Or Current Enrollment In An Investigational Trial Will Also Exclude Them From This Study. Lastly, The Use Of Inhaled Tobacco Or Illegal Substances Is Not Permitted In Order To Participate.
Gossamer, Oral Inhalation, Pdgfr Kinase Inhibitor
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