An extension study, at multiple study sites, for patients with Pulmonary Arterial Hypertension who took part in study CXA-10-301, to look at the continuing safety of CXA-10 and how well it works long term: all patients will receive CXA-10 treatment.
- Conditions
- Pulmonary Arterial Hypertension (PAH).MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-002414-40-GB
- Lead Sponsor
- Complexa Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 115
1. 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.
2. Is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
3. Has completed the CXA-10-301 study and demonstrated compliance with study medication administration and all study requirements.
4. If receiving simvastatin-containing products: simvastatin (Zocor), Vytorin, or any other combination therapy containing simvastatin, simvastatin dose does not exceed 20 mg/day.
5. 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.
6. Women of childbearing potential and males with partners of childbearing potential must agree to use a reliable method of contraception while taking study medication. Acceptable methods of birth control are defined in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. Severe hypotension: systolic blood pressure <90 mmHg (sitting) at Baseline (Visit 1).
2. Hypertensive: >160 mmHg systolic or >110 mmHg diastolic (sitting) at Baseline (V1).
3. QTcF on supine ECGs at Baseline (V1) of >500 msec.
4. 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 (V1).
5. Recent cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days prior to Baseline (V1).
6. Recent hospitalization for left heart failure within the last 90 days prior to Baseline (V1).
7. 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.
8. Chronic atrial fibrillation and life-threatening cardiac arrhythmias.
9. Personal or family history of congenital prolonged QTc syndrome or sudden unexpected death due to a cardiac reason.
10. Clinically significant anemia in the opinion of the investigator that precludes enrollment into this study, or Hb <9 gm/dl.
11. Severe hepatic impairment (Child-Pugh class C with or without cirrhosis) at Baseline (V1) or active chronic hepatitis.
12. Received intravenous inotropes within 2 weeks prior to Baseline (V1) (e.g. dopamine, dobutamine).
13. History of angina pectoris or other condition that was treated with long or short acting nitrates <12 weeks of Baseline (V1).
14. History of herbal or natural medication use (including fish oil) within 2 weeks or 5 half-lives, whichever is longer, prior to Baseline (V1).
15. Received prednisone at doses >15 mg/ day or changes in immunosuppressive medications <12 weeks prior to Baseline (V1).
16. Currently taking a drug that may affect the assay measurement of serum creatinine (e.g. cimetidine, Bactrim, Pyridium).
17. 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 (V1) with no anticipated changes to the dose or regimen during the course of the study).
18. Currently taking dimethyl fumarate (Tecfidera™).
19. Any of the following laboratories abnormal and unresolved in CXA-10-301:
a. Absolute lymphocyte counts < 0.5 x 10^9 cells/L.
b. Aspartate aminotransferase and/or alanine aminotransferase > 3.0X upper limit of normal (ULN), alkaline phosphatase > 2X ULN of liver origin, and total bilirubin >2X ULN. If all liver function tests (LFTs) are within normal limits 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.
c. eGFR < 30 mL/min/1.73 m2 (estimated by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine/Cystatin C 2012 algorithm) at Baseline (Visit 1).
20. Females who are pregnant or breastfeeding, or who are trying to conceive.
21. Recent (within 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method