PAH Clinical Trial
— PAHOfficial title:
Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension
Verified date | August 2020 |
Source | Complexa, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.
Status | Terminated |
Enrollment | 69 |
Est. completion date | August 5, 2020 |
Est. primary completion date | August 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Males and females between 18 to 80 years of age inclusive at Screening - Weight =40 kg - Must have a diagnosis of WHO Group 1 PH - Have a World Health Organization (WHO) Classification of Functional Status Class II or III of patients with PH - Must meet hemodynamic criteria by means of a right heart catheterization - Meet pulmonary function test parameters - A 6 MWD test of =125m and =550m at the visit - Subjects must have a resting arterial oxygen saturation (SaO2) =90%, with or without supplemental oxygen, as measured by pulse oximetry at Screening - Subjects enrolled in a prescribed exercise program for pulmonary rehabilitation must be in a stable program for 3 months prior to Screening (Visit 1) and must agree to maintain their current level of rehabilitation throughout the study. If subjects are not enrolled in a prescribed exercise training program for pulmonary rehabilitation, they cannot enroll during the Screening/Baseline Period or throughout the study - If receiving simvastatin-containing products: dose should not exceed 20 mg/day - Subjects must be receiving no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists and must be on stable doses (=3 months) at Screening (Visit 1) Exclusion Criteria: - Contraindications for CMRI imaging - WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension - Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension) - QTcF > 500 msec - Acute myocardial infarction or acute coronary syndrome within the last 90 days - Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days - Hospitalization for left heart failure within the last 90 days - Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF < 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion - Chronic atrial fibrillation and life-threatening cardiac arrhythmias - Personal or family history of congenital prolonged QTc syndrome or sudden or sudden unexpected death due to a cardiac reason - Clinically significant anemia - Severe hepatic impairment or active chronic hepatitis - Receiving intravenous inotropes within 2 weeks prior to Screening - History of angina pectoris or other condition that was treated with long or short acting nitrates <12 weeks of Screening - Received prednisone doses >15mg/day or changes in immunosuppressive medications < 12 weeks prior to Screening (Visit 1) - Recent (within 1 year) history of abusing alcohol or illicit drugs. - History of any primary malignancy, with no evidence of disease for at least 5 years - Treatment with any investigational drug or device within 30 days or 5 half-lives |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Golden Jubilee National Hospital | Glasgow | |
United Kingdom | Hammersmith Hospital | London | |
United Kingdom | Royal Brompton | London | |
United Kingdom | Royal Free | London | |
United Kingdom | Freeman Hospital | Newcastle Upon Tyne | |
United Kingdom | Royal Hallamshire Hospital | Sheffield | |
United States | University of New Mexico Health Sciences Center | Albuquerque | New Mexico |
United States | University of Colorado Health | Aurora | Colorado |
United States | University of Alabama | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | University of Virginia School of Medicine | Charlottesville | Virginia |
United States | University of Chicago | Chicago | Illinois |
United States | Christ Hospital-Lindner Research Center | Cincinnati | Ohio |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | The Ohio State University | Columbus | Ohio |
United States | UT Southwestern | Dallas | Texas |
United States | National Jewish Health | Denver | Colorado |
United States | Duke University | Durham | North Carolina |
United States | Texas Tech | El Paso | Texas |
United States | Inova Medical Campus | Falls Church | Virginia |
United States | University of Florida Health | Gainesville | Florida |
United States | Penn State M.S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Houston Methodist | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | Mayo Clinic | Jacksonville | Florida |
United States | University of Kansas | Kansas City | Kansas |
United States | Loyola University | Maywood | Illinois |
United States | University of Miami | Miami | Florida |
United States | Froedert Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesotta | Minneapolis | Minnesota |
United States | Vanderbuilt University | Nashville | Tennessee |
United States | NYU Langone Medical Center | New York | New York |
United States | Sentara Medical Group | Norfolk | Virginia |
United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
United States | AdventHealth | Orlando | Florida |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Arizona Pulmonary Specialists | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | Washington University and Barnes Jewish Hospital | Saint Louis | Missouri |
United States | University of California San Francisco | San Francisco | California |
United States | University of Arizona | Tucson | Arizona |
United States | George Washington Medical Faculty Associates | Washington | District of Columbia |
United States | Washington Hospital (Medstar) | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Complexa, Inc. | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), Cardiovascular Clinical Science Foundation, Innovative Analytics, Medpace, Inc., MicroConstants, Philips Healthcare |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Right Ventricular Ejection Fraction (RVEF) | • To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by Cardiac MRI | 6 months | |
Primary | Pulmonary Vascular Resistance (PVR) | • To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC) | 6 months | |
Secondary | 6 Minute Walk Distance (6MWD) | To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by 6 minute walk distance (6MWD) | 6 months |
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