Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04125745|
Recruitment Status : Terminated (negative study outcome from Complexa's multicenter clinical trial; no safety concerns)
First Posted : October 14, 2019
Results First Posted : January 12, 2022
Last Update Posted : January 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: CXA-10||Phase 2|
This is a single-center, one-arm, open-label proof of concept safety study and a phase 2a proof of efficacy pre- and post-assessment study of oral CXA-10 for the treatment of pulmonary arterial hypertension.
The investigators hypothesize that administration of CXA-10 for 12 weeks will improves exercise capacity, cardiovascular function and health related quality of life in pulmonary arterial hypertension patients with limited toxicity.
Subjects who meet the inclusion criteria and none of the exclusion criteria will be scheduled within 4 weeks of screening to receive oral CXA-10 at the dose of 300 mg once daily followed by 12 weeks of open-label CXA-10 treatment and then a 4-week safety follow-up. Additional follow-up assessments by telephone will occur in between each outpatient clinic visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||One-arm, open-label|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension|
|Actual Study Start Date :||October 31, 2019|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||December 1, 2020|
Oral CXA-10 300 mg once daily for 12 weeks
Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks
Other Name: 10-nitro-9(E)-octadec-9-enoic acid
- Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0 in 12 Weeks [ Time Frame: Baseline to 12 Weeks ]Numbers of treatment-related adverse events is assessed by CTCAE v4.0
- Change From Baseline in Pulmonary Vascular Resistance is Measured at Baseline and 12 Weeks by Right Heart Catheterization [ Time Frame: Baseline and 12 Weeks ]Pulmonary vascular resistance (PVR) will be measured by right heart catheterization; results reported as changed from baseline in Woods units. PVR is calculated as (mean pulmonary artery pressure - pulmonary artery wedge pressure)/cardiac output, where pressures are in units of mm Hg and cardiac output is in units of L/min. Pulmonary hypertension is defined as PVR > 3 Woods units. A negative change implies a decrease in PVR which would be considered an improvement.
- Change From Baseline in Mean Pulmonary Artery Pressure is Measured at Baseline and 12 Weeks by Right Heart Catheterization [ Time Frame: Baseline and 12 Weeks ]Pulmonary Artery mean pressure will be measured by right heart catheterization
- Change From Baseline in RV Function as Measured by Tricuspid Annular Plane Systolic Excursion (TAPSE) as Assessed by Echocardiograms at 12 Weeks [ Time Frame: at baseline and 12 weeks ]Change from baseline in RV function as measured by tricuspid annular plane systolic excursion (TAPSE) as assessed by echocardiograms at 12 weeks
- Changes From Baseline in Functional Exercise Capacity by Assessing 6 Minute Walk Distance Test [ Time Frame: at baseline and 12 weeks ]Change from baseline in 6 minute walk distance at 12 weeks
- Change From Baseline in Levels of Serum N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at 12 Weeks [ Time Frame: at Baseline and 12 Weeks ]Blood samples will be collected for NT-proBNP analysis
- Change From Baseline in Functional Status of Patients as Assessed by New York Heart Association Functional Class [ Time Frame: at Baseline and 12 Weeks ]
The New York Heart Association Classification of Functional Status of Patients with pulmonary hypertension will be used to classify disease severity in PAH. It places patients in one of four categories based on how much they are limited during physical activity.
Measure Description: Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of dyspnea at rest. If any physical activity is undertaken, discomfort increases.
- Change From Baseline in Daily Physical Activity as Measured by a Accelerometer [ Time Frame: Baseline and 12 Weeks ]Continuous physical activity monitoring will be conducted using a noninvasive accelerometer. The device must be worn for a minimum of 7 days at home prior to receiving the first dose of the study drug and prior to the end of the study drug treatment at week 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125745
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Marc Simon, MD||University of Pittsburgh|