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Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial) (EXACT)

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ClinicalTrials.gov Identifier: NCT04125732
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
XyloCor Therapeutics, Inc.

Brief Summary:
The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemia Angina Refractory Cardiovascular Diseases Heart Diseases Biological: AdVEGFXC1 Phase 1 Phase 2

Detailed Description:
This is a Phase 1/2, first-in-human, multicenter, open-label, single arm dose escalation trial of XC001. Approximately 12 subjects (N=3 per cohort) who have refractory angina will be enrolled into 4 ascending dose groups, followed by an expansion of the highest tolerated dose with 17 additional subjects. XC001 will be administered by a transthoracic epicardial procedure. Safety will be the focus for the initial 6 months after XC001 administration followed by one safety focused telephone evaluation at Month 12.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: AdVEGFXC1 at 1x10^9 vp Biological: AdVEGFXC1
AdVEGFXC1 at one of 4 doses
Other Name: XC001

Experimental: AdVEGFXC1 at 1x10^10 vp Biological: AdVEGFXC1
AdVEGFXC1 at one of 4 doses
Other Name: XC001

Experimental: AdVEGFXC1 at 4x10^10 vp Biological: AdVEGFXC1
AdVEGFXC1 at one of 4 doses
Other Name: XC001

Experimental: AdVEGFXC1 at 1x10^11 vp Biological: AdVEGFXC1
AdVEGFXC1 at one of 4 doses
Other Name: XC001




Primary Outcome Measures :
  1. Primary Endpoint (adverse events) [ Time Frame: 6 months ]
    Safety, as assessed by adverse events and serious adverse events


Secondary Outcome Measures :
  1. Secondary Endpoint (Exercise tolerance test) [ Time Frame: 6 months ]
    Exercise tolerance test

  2. Secondary Endpoint (Seattle Angina Questionnaire) [ Time Frame: 6 months ]
    Seattle Angina Questionnaire

  3. Secondary Endpoint (Canadian Cardiovascular Society angina class) [ Time Frame: 6 months ]
    Canadian Cardiovascular Society angina class

  4. Secondary Endpoint (Angina episodes) [ Time Frame: 6 months ]
    Angina episodes



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, age 18 to 80 years
  • Diagnosis of chronic angina due to obstructive coronary artery disease that is refractory to drug therapy and unsuitable for revascularization via coronary artery bypass graft or percutaneous coronary intervention
  • Angina class II-IV based on Canadian Cardiovascular Society Classification of Angina Pectoris
  • Adequate hematologic (hemoglobin ≥ 10 g/dL, absolute neutrophil count > 1.2 × 10^3 per μL and platelet count ≥ 75,000 per μL), hepatic (alanine aminotransferase and aspartate aminotransferase ≤ 3 x ULN; total bilirubin ≤ 2 x ULN), and renal function (glomerular filtration rate > 29 mL/minute/1.73 m2)
  • Adequate birth control if of child-bearing potential
  • Must be willing and able to provide informed consent

Exclusion Criteria:

  • ST elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI) not requiring revascularization, transmural myocardial infarction or cerebral vascular accident within the past 30 days
  • New York Heart Association Function Class III or IV or left ventricular ejection fraction < 25% within the 6 weeks prior to the screening visit
  • HbA1c ≥ 9.5%, SBP <90 or >180 mmHg, DBP >100 mmHg
  • Other concurrent medical conditions that could jeopardize the safety of the subject or objectives of the study

Information from the National Library of Medicine

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): NCT04125732


Contacts
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Contact: Mark Peterson 888-290-0081 mark.peterson@xylocor.com

Sponsors and Collaborators
XyloCor Therapeutics, Inc.

Publications:
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Responsible Party: XyloCor Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04125732     History of Changes
Other Study ID Numbers: XC001-1001
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by XyloCor Therapeutics, Inc.:
Refractory angina
Coronary Artery Disease
Gene Therapy
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Angina Pectoris
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms