AzTrials
AzTrials

PAHPhase 2NCT04053543

CXA-10 Study in Subjects With Pulmonary Arterial Hypertension

A Phase 2 study testing CXA-10 in people with PAH, run by Complexa, Inc. at 37 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PAH
What is being tested?
CXA-10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
37 sitesin 2 countries
Study dates
9 Aug 2019to 12 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 30Show fewer
  • 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.
  • Currently taking a drug that may affect the assay measurement of serum creatinine (e.g. cimetidine, Bactrim, Pyridium). A list is provided in Appendix H.
  • 21. Newly prescribed drug or increased dose of an existing drug that is known to prolong the QTc interval and has been associated with Torsades de Pointes (TdP) identified in the CredibleMeds.org website list as known risk (KR) of TdP.
  • Note: Stable doses of drugs classified as conditional risk (CR) of TdP or possible risk (PR) of TdP are permitted (i.e., subject has received the same dose and regimen for at least 30 days prior to Baseline with no anticipated changes to the dose or regimen during the course of the study).
  • 22. Currently taking dimethyl fumarate (Tecfidera™).
  • 23. Any of the following laboratories abnormal and unresolved in CXA-10-301:
  • Absolute lymphocyte counts < 0.5 x 109 cells/L.
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3.0X upper limit of normal (ULN), alkaline phosphatase (AP) > 2X ULN of liver origin, and total bilirubin >2X ULN. If all liver function tests (LFTs) are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted to evaluate for Rotor's/Gilbert's Syndrome. Subjects with Rotor's/Gilbert's Syndrome may be enrolled.
  • eGFR < 30 mL/min/1.73 m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine/Cystatin C 2012 algorithm) at Baseline.
  • 24. Females who are pregnant or breastfeeding, or who are trying to conceive. 25. Recent (within 1 year) history of abusing alcohol or illicit drugs. 26. History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, or other malignancies (such as thyroid or testicular) that have been curatively treated and with no evidence of disease for at least 3 years or prostate cancer who is not currently or expected, during the study, to undergo radiation therapy, chemotherapy, and/or surgical intervention, or to initiate hormonal treatment.
  • Exception: subjects with history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ are eligible for enrollment.
  • 27. Cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, central nervous system or psychiatric disease that, in the opinion of the investigator, may adversely affect the safety of the subject and/or efficacy of the investigational product or severely limit the lifespan of the subject other than the condition being studied.
  • 28. Clinically significant hyperthyroidism or hypothyroidism not adequately treated.
  • 29. Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non- compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).
  • 30. Known hypersensitivity to CXA-10, the metabolites, or formulation excipients.
  • 31. Treatment with any investigational drug (other than CXA-10) or device within 30 days or 5 half-lives (whichever is longer) prior to Baseline (this includes investigational formulations of marketed products, inhaled and topical drugs), or plans to participate in an investigational drug or device study at any time during this study.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States31 sites

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • University of Alabama

    Birmingham, Alabama, 35233

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22908

  • University of Chicago

    Chicago, Illinois, 60637

  • Christ Hospital-Lindner Research Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • UT Southwestern

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University

    Durham, North Carolina, 27710

  • Texas Tech

    El Paso, Texas, 79905

  • Inova Medical Campus

    Falls Church, Virginia, 22042

  • University of Florida Health

    Gainesville, Florida, 32608

  • Houston Methodist

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of California San Diego

    La Jolla, California, 92037

  • University of Miami

    Miami, Florida, 33136

  • Froedert Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesotta

    Minneapolis, Minnesota, 55455

  • Vanderbuilt University

    Nashville, Tennessee, 37232

  • NYU Langone Medical Center

    New York, New York, 10279

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of California San Francisco

    San Francisco, California, 94143-2202

  • Washington University and Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • University of Arizona

    Tucson, Arizona, 85724

  • Washington Hospital (Medstar)

    Washington D.C., District of Columbia, 20010

  • George Washington Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

United Kingdom6 sites

  • Golden Jubilee National Hospital

    Glasgow, G81 4DY

  • Royal Free

    London, NW3 2QG

  • Royal Brompton

    London, SW3 6HP

  • Hammersmith Hospital

    London, W12 0HS

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

About this study

Official title: A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301

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.

Read the detailed description

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.

The study will be performed in approximately 50 study centers across the United States and the United Kingdom, which participated in CXA-10-301. Approximately 96 subjects who completed treatment in CXA-10-301 will be eligible to participate in this OLE study, after completing all Visit 9 (Day 1 and Day 2) assessments in CXA-10-301.

Study participation for each subject will last up to approximately 6.5 months. The study will consist of a 6 month open-label treatment period and require 5 clinic visits and 1 telephone visit, including the Baseline Visit completed simultaneously with Visit 9 CXA-10-301, plus a follow-up visit approximately 2 weeks following the last dose of CXA-10.

Conditions
PAH
Being tested
CXA-10
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
Medical subject headings
Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Hypertension, Familial Primary Pulmonary Hypertension, Connective Tissue Diseases, Vascular Diseases, Lung Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CXA-10Drug

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

Study groups in NCT04053543
Study groupRoleWhat they receive
150mg CXA-10ExperimentalOnce daily dosing of 150mg CXA-10 in the morning
Receives: Drug: CXA-10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of AEs

    Adverse events occurring during the treatment period

    Measured: 6 months

  2. Changes in respiration

    Change from baseline values at each post-baseline time point

    Measured: 6 months

  3. Changes in heart rate

    Change from baseline values at each post-baseline time point

    Measured: 6 months

  4. Changes in blood pressure

    Change from baseline values at each post-baseline time point

    Measured: 6 months

Secondary outcomes (4)

  1. PAH-specific medication changes

    Addition or removal of PAH-specific medications, including any dose changes

    Measured: 6 months

  2. 6 Minute Walk Distance

    Change from baseline in 6-minute walk distance (6MWD)

    Measured: 6 months

  3. Who Classification of Functional Status

    Change from baseline in WHO Classification of Functional Status of Patients with PH

    Measured: 6 months

  4. Clinical worsening

    Death from any cause, hospitalization for worsening PAH, Disease progression, unsatisfactory long-term clinical response

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2019
  2. Study start9 Aug 2019
  3. Primary completion12 Aug 2020
  4. Study completion12 Aug 2020

Why it stopped: LOE

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
CXA-10
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053543
Sponsor's protocol ID
CXA-10-2302
Status last verified
Aug 2020
First submitted
19 Jul 2019
Last updated
26 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CXA-10 in people with PAH, run by Complexa, Inc. at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: LOE). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AEs (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in