[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

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Condition

Cardiovascular Diseases,Congestive Heart Failure,Heart Arrhythmia,Heart Disease, Ischemic,Heart Failure,Heart Failure, Diastolic,Heart Failure, Systolic,Heart Failure,Congestive,Heart; Complications

Treatment type

Interventional

Investigational product

3 x 10e13vg NAN-101

Phase

Phase 1

Sponsor

Asklepios Biopharmaceutical, Inc.

ClinicalTrials.gov identifier

NCT04179643

Study number

NAN-CS101

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About the study

This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic congestive heart failure will be enrolled until up to 12 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Age >18 years of age
  2. Chronic non-ischemic cardiomyopathy
  3. LVEF ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to enrollment
  4. NYHA Class III HF for a minimum of 6 months HF despite appropriate medical therapy (defined below):
  5. Treatment with appropriate HF therapy as tolerated, including, but not limited to:
  6. Beta blocker therapy and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment. May also receive aldosterone antagonist therapy. Doses of the above medications must be stable for ≥ 30 days prior to enrollment; and
  7. Cardiac resynchronization therapy (CRT), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment
  8. Females of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:
  9. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to IP administration
  10. Intrauterine device in place for at least 90 days prior to receiving IP
  11. Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior to receiving IP
  12. Abstinence (the subject must be willing to remain abstinent from screening to 6 months after receiving IP). Females are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject
  13. Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to IP administration
  14. Hormonal contraceptives starting > 90 days prior to IP. If hormonal contraceptives are started less than 90 days prior to receiving IP, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives
  15. Males subjects capable of fathering a child:
  16. Must agree to use a condom from IP administration through 6 months after the time of IP administration
  17. Must agree not to donate sperm for 6 months after time of receiving IP
  18. Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP is an acceptable form of contraception
  19. Males who claim abstinence as their method of contraception are allowed provided they agree to use barrier methods should they become sexually active from screening through 6 months after receiving IP. Males are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject
  20. Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form
  21. Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist
Exclusion criteria
  1. Chronic ischemic cardiomyopathy
  2. Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment
  3. Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm
  4. Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to enrollment
  5. Third degree heart block
  6. Clinically significant myocardial infarction (MI) in the judgment of the subject's physician (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to enrollment
  7. Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt
  8. Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction surgery, heart transplant, conventional revascularization procedure, or valvular repair within 3 months of IP dosing
  9. Known hypersensitivity to contrast dyes used for angiography; history of, or likely need for, high-dose steroid pretreatment prior to contrast angiography
  10. Expected survival < 1 year in the judgment of the investigator
  11. Active or suspected infection within 48 hours prior to enrollment as evidenced by fever or positive culture
  12. Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or hepatitis C virus infection). If serology is positive and PCR is negative, subject may be eligible (confirm with medical monitor).
  13. Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase) > 2x upper limit of normal (ULN) within 30 days prior to enrollment.
  14. Renal Failure, dialysis dependent or serum creatinine > 2.5 mg/dl within 30 days prior to enrollment
  15. Bleeding diathesis or thrombocytopenia defined as platelets <50,000 platelets/μL within 30 days prior to enrollment
  16. Anemia defined as hemoglobin <10 g/dL or transfusion dependent within 30 days prior to enrollment
  17. Neutropenia defined as absolute neutrophils <1500 mm3 within 30 days prior to enrollment
  18. Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3
  19. Previous participation in a study of gene transfer
  20. Receiving investigational intervention or participating in another clinical study within 30 days or within 5 half-lives of another investigational drug administration prior to administration of NAN-101 that may impact the therapeutic potential of NAN-101.
  21. Pregnancy or breastfeeding at the time of screening

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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