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Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy

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ClinicalTrials.gov Identifier: NCT01657045
Recruitment Status : Unknown
Verified July 2013 by SironRX Therapeutics, Inc..
Recruitment status was:  Recruiting
First Posted : August 3, 2012
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
SironRX Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 1, 2012
First Posted Date  ICMJE August 3, 2012
Last Update Posted Date July 23, 2013
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2012)
To investigate the safety and tolerability of ascending doses of JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2012)
To investigate the preliminary efficacy of ascending doses JVS-100 delivered via needle-free dermal injections to subjects receiving surgical incisions following cardiothoracic surgery. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
Official Title  ICMJE A Phase I Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Needle-free Dermal Injection to Cohorts of Adults Receiving Surgical Sternotomy Incisions
Brief Summary This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16 - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be delivered along the edge of the sternal wound using a needle-free injection device that has FDA-clearance for subcutaneous injections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Median Sternotomy
Intervention  ICMJE Biological: JVS-100 or placebo
Injections will be delivered depending on sternal incision length.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Subjects will be randomized to receive injections JVS-100 or placebo.
    Intervention: Biological: JVS-100 or placebo
  • Experimental: Cohort 2
    Subjects will be randomized to receive injections JVS-100 or placebo.
    Intervention: Biological: JVS-100 or placebo
  • Experimental: Cohort 3
    Subjects will be randomized to receive injections of JVS-100 or placebo.
    Intervention: Biological: JVS-100 or placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 22, 2013)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2012)
48
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women 40 - 80 years of age inclusive
  • Patients undergoing median sternotomy for cardiac surgical procedures, with incision length of 16-25 cm
  • Subject must be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent
  • Subjects with BMI 25 - 40 kg/m2
  • All subjects age 50 or older must have had a Fecal occult blood test (FOBT) or fecal immunochemical test (FIT) that was negative within the last year or a colonoscopy within the last 10 years
  • Women age 40 - 65 must have had a Papanicolaou (PAP) test that was negative within the last 5 years unless a total hysterectomy has been previously performed for benign disease
  • Women age 40 or older must have had a mammogram that was negative within the last year
  • All diabetic subjects must have had an ophthalmologic exam within the last year showing no active proliferative retinopathy.

Exclusion Criteria:

  • Subject is scheduled for mechanical device assistance or, heart transplantation
  • Class IV heart failure
  • Subject had acute myocardial infarction less than 3 days prior to scheduled surgery
  • Subject is undergoing urgent bypass surgical procedure
  • History of scleroderma, a connective tissue disorder, rheumatoid arthritis, or ankylosing spondylitis or systemic lupus erythematosus (SLE)
  • Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control
  • Life expectancy of < 1 year
  • Diabetes mellitus with HgbA1C >10.5% tested within 2 weeks prior to surgery
  • Existing scarring in the area of study
  • Subject has received a cytotoxic agent or has a history of chest radiation therapy and/or will likely require such treatment in the 30 day period following surgery, not including use of radiation for diagnostic imaging, e.g., PET Scan, CT SCAN, Fluro, Myocardial Perfusion (SPECT).
  • Chest tattoos over the sternum, breast implants, prior mastectomies or lumpectomies
  • Subject plans to use an alternative/accessory wound healing treatment
  • Infection being treated with systemic antibiotics within 3 days of scheduled surgery
  • Chronic kidney disease (stage 5) requiring dialysis
  • Significant Hepatic disease
  • Significant is known to be infected with HBV, HIV or HCV
  • Clinically significant elevations or decreases in PT/PTT/INR/WBC
  • Concurrent medical condition that is associated with prolonged recovery from surgery (e.g., significant respiratory disease, high risk for ventilator dependence, current use of systemic steroids)
  • Subject has cognitive impairment
  • Any patient with a history of cancer with the exception of: 1) The cancer was limited to curable non-melanoma skin malignancies; 2) The cancer was removed by a successful tumor resection, with or without radiation or chemotherapy treatment, 5 years or more prior to enrollment in this study without recurrence.
  • Men unwilling to agree to barrier contraception unless previously received a vasectomy
  • Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
  • Previous treatment with an angiogenic growth factor or with stem cell therapy within 1 year
  • Participation in another clinical trial of an investigational agent in the previous 30 days
  • History of drug or alcohol abuse in the past year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01657045
Other Study ID Numbers  ICMJE SRX-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SironRX Therapeutics, Inc.
Study Sponsor  ICMJE SironRX Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amit Patel, MD University of Utah
Principal Investigator: Robert Michler, MD Montefiore Medical Center
PRS Account SironRX Therapeutics, Inc.
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP