PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
- Registration Number
- NCT03449524
- Lead Sponsor
- Complexa, Inc.
- Brief Summary
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.
- Detailed Description
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.
The study will be performed in approximately 50 study centers across the United States of America and Europe. The recruitment period is anticipated to be approximately 24 months. Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the study.
Study participation for each subject will last approximately 8 months. The study will consist of a screening period (within 30 days prior to dosing), 180 days (approximately 6 months) treatment period and approximately 14 days follow-up period after the end of treatment visit.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 69
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 75mg CXA-10 75mg CXA-10 Once daily dosing of 75mg CXA-10 in the morning Placebo Placebo Once daily dosing in the morning 150mg CXA-10 150mg CXA-10 Once daily dosing of 150mg CXA-10 in the morning
- Primary Outcome Measures
Name Time Method Right Ventricular Ejection Fraction (RVEF) 6 months • 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
Pulmonary Vascular Resistance (PVR) 6 months • 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)
- Secondary Outcome Measures
Name Time Method 6 Minute Walk Distance (6MWD) 6 months 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)
Trial Locations
- Locations (46)
University of Arizona
🇺🇸Tucson, Arizona, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Washington Hospital (Medstar)
🇺🇸Washington, District of Columbia, United States
George Washington Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
AdventHealth
🇺🇸Orlando, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
Royal Free
🇬🇧London, United Kingdom
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Royal Brompton
🇬🇧London, United Kingdom
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
NYU Langone Medical Center
🇺🇸New York, New York, United States
Loyola University
🇺🇸Maywood, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Penn State M.S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Texas Tech
🇺🇸El Paso, Texas, United States
Inova Medical Campus
🇺🇸Falls Church, Virginia, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
Washington University and Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Virginia School of Medicine
🇺🇸Charlottesville, Virginia, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Arizona Pulmonary Specialists
🇺🇸Phoenix, Arizona, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Health
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Miami
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Minnesotta
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Christ Hospital-Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbuilt University
🇺🇸Nashville, Tennessee, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Froedert Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States