CXA-10 Study in Subjects With Pulmonary Arterial Hypertension

NCT04053543 | Terminated Phase 2 FDA Drug

• 1 other identifier: CXA-10-2302
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 37

Brief Summary

This is a Phase 2, multicenter, open-label extension (OLE) of study CXA-10-301, to evaluate the long term safety and efficacy of daily dosing of CXA-10.

Conditions

PAH

Keywords

Pulmonary Arterial Hypertension; Pulmonary Hypertension; PAH; Connective Tissue Disease- Associated; 6 Minute Walk Test; 6 Minute Walk Distance; Pulmonary Vascular Resistance; Cardiac MRI; Right Ventricular Function; Hypertension; Familial Primary Pulmonary Hypertension; Connective Tissue Diseases; Vascular Diseases; Hypertension, Pulmonary; Lung Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Incidence of AEs

  Adverse events occurring during the treatment period

  6 months

• Changes in respiration

  Change from baseline values at each post-baseline time point

  6 months

• Changes in heart rate

  Change from baseline values at each post-baseline time point

  6 months

• Changes in blood pressure

  Change from baseline values at each post-baseline time point

  6 months

Secondary Outcomes (4)

• PAH-specific medication changes

  6 months

• 6 Minute Walk Distance

  6 months

• Who Classification of Functional Status

  6 months

• Clinical worsening

  6 months

Study Arms (1)

150mg CXA-10

EXPERIMENTAL

Once daily dosing of 150mg CXA-10 in the morning

Drug: CXA-10

Interventions

CXA-10 DRUG

(10-nitro-9(E)-octadec-9enoic acid)

150mg CXA-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document indicating subject has been informed of all pertinent aspects of the study prior to initiation of any study-required procedures.
• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
• Has completed the CXA-10-301 study and demonstrated compliance with study medication administration and study requirements.
• If receiving simvastatin-containing products: simvastatin (Zocor), Vytorin, or any other combination therapy containing simvastatin, simvastatin dose does not exceed 20 mg/day.
• Currently receiving no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonists (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists.
• Women of childbearing potential and males with partners of childbearing potential must agree to use a reliable method of contraception while taking study medication.

You may not qualify if:

• Severe hypotension defined by systolic blood pressure \<90 mmHg from sitting blood pressure measurement at Baseline.
• Hypertensive defined by \>160 mmHg systolic or \>110 mmHg diastolic from sitting blood pressure measurement at Baseline.
• QTcF on supine ECGs at Baseline (Visit 1) of \>500 msec.
• Acute myocardial infarction or acute coronary syndrome (ST-Elevation Myocardial Infarction \[STEMI\], Non STEMI \[NSTEMI\] and or unstable angina) within the last 90 days prior to Baseline.
• Recent cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days prior to Baseline.
• Recent hospitalization for left heart failure within the last 90 days prior to Baseline.
• 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, in the opinion of the investigator.
• Chronic atrial fibrillation and life-threatening cardiac arrhythmias.
• Personal or family history of congenital prolonged QTc syndrome or sudden unexpected death due to a cardiac reason.
• Clinically significant anemia in the opinion of the investigator that precludes enrollment into this study, or Hb \<9 gm/dl.
• Severe hepatic impairment (Child-Pugh class C with or without cirrhosis) at Baseline or active chronic hepatitis.
• Received intravenous inotropes within 2 weeks prior to Baseline (e.g. dopamine, dobutamine).
• History of angina pectoris or other condition that was treated with long or short acting nitrates \<12 weeks of Baseline.
• History of herbal or natural medication use (including fish oil) within 2 weeks or 5 half-lives, whichever is longer, prior to Baseline.
• Received prednisone at doses \> 15 mg/ day or changes in immunosuppressive medications \<12 weeks prior to Baseline.

Sponsors & Collaborators

• Complexa, Inc.: lead
• Medpace, Inc.: collaborator
• Innovative Analytics: collaborator
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator

Study Sites (37)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

University of California San Francisco

San Francisco, California, 94143-2202, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Washington Hospital (Medstar)

Washington D.C., District of Columbia, 20010, United States

Location

George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

University of Florida Health

Gainesville, Florida, 32608, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of Minnesotta

Minneapolis, Minnesota, 55455, United States

Location

Washington University and Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

NYU Langone Medical Center

New York, New York, 10279, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Christ Hospital-Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbuilt University

Nashville, Tennessee, 37232, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Texas Tech

El Paso, Texas, 79905, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

Inova Medical Campus

Falls Church, Virginia, 22042, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Froedert Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Royal Free

London, NW3 2QG, United Kingdom

Location

Royal Brompton

London, SW3 6HP, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension; Familial Primary Pulmonary Hypertension; Connective Tissue Diseases; Vascular Diseases; Lung Diseases; Cardiovascular Diseases

Interventions

CXA-10

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Skin and Connective Tissue Diseases

Study Officials

• Theo Danoff, MD

  Complexa, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CXA-10

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 12, 2019
• Study Start: August 9, 2019
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

US (31); GB (6)