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A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. Clinical research trials and A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.. A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. clinical trial. Test subjects typically receive the most expert healthcare available for their A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia. condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.  A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
For Condition: Peripheral Vascular Disease,Ischemia,Arterial Occlusive Disease
Status: Recruiting
Sponsor(s): AnGes , Daiichi Pharmaceuticals
Synopsis: The primary purpose of this study is to assess the overall safety of different dose regimens of AMG0001 as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study will also evaluate the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.
Details: The primary goal of this study is to assess the safety of AMG0001, detect potential angiogenesis response to AMG0001 treatment and to correlate these changes to clinical endpoints dependent upon improvement in tissue perfusion for relief of CLI complications. The objectives of this study are: Assess the overall safety of different exposure regimens of AMG0001 in the CLI subject population. Evaluate the potential effect of angiogenesis associated with different doses and dose regimens of AMG0001 as measured by improvement in tissue perfusion. Evaluate the activity of different exposure regimens of AMG0001 to benefit clinical outcomes of reduction of amputation and mortality, wound healing, rest-pain reduction and improvement in subjectÂ’s ability to function without adverse consequences on quality of life.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene. - The subject will have a TcPO2 of < 40 mmHg. - Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease: A. Ankle systolic pressure of < 60 mmHg B. Toe systolic pressure < 40 mmHg. - The subject is a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy, or poor operative risk. - Subject has signed an informed consent form either directly or through a legally authorized representative - If female, the subject must be (a) at least one year post-menopausal, or (b) surgically sterile, or (c) if the subject is of child-bearing potential, she must have been practicing contraception for at least 12 weeks prior to entering the study. - If subject is of reproductive potential, he or she must be using an accepted and effective (barrier) form of birth control during the study. Exclusion Criteria: - Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation (at or above the ankle) within 4 weeks of start of treatment. - Subjects with a diagnosis of Buerger’s disease (Thromboangitis Obliterans). - Subjects with hemodynamically significant aorto-iliac occlusive disease. - Subjects who have had a revascularization procedure within 12 weeks prior to treatment initiation that remains patent. Revascularization procedures that are evidenced to have failed for >2 weeks prior to treatment initiation are acceptable. - Subjects with no detectable signal via Doppler (complete occlusion) in the dorsalis pedis, posterior tibial, or toe arteries. - Evidence or history of malignant neoplasm (clinical, laboratory or imaging), except for basal cell carcinoma of the skin. - Subjects who have proliferative diabetic retinopathy or severe, non-proliferative retinopathy - Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by a creatinine of > 2.5, or receiving chronic hemodialysis therapy. - A subject who has hepatic cirrhosis, viral hepatitis, or is HIV positive. - Subjects with a clinically significant liver enzyme abnormality (i.e., AST or ALT more than two times the upper limit of normal and/or bilirubin more than 50% the upper limit of normal). - Subjects requiring the use of hyperbaric oxygen treatment for wound healing during the screening and 6 month follow-up period.
Total Enrollment: 100
Location and Contact Information:
Medical College of Ohio *Recruiting*
Toledo, Ohio, 43614
United States
Recruiting Christopher Cooper 419-383-3697
The Ochsner Heart and Vascular Institute *Recruiting*
Metairie, Louisiana, 70002
United States
Recruiting Corey Goldman 504-842-9567
University of Rochester *Recruiting*
Rochester, New York, 14642
United States
Recruiting Mark Davies 585-275-5690
VA Medical Center Surgical Service (112) *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Anton Sidawy 202-745-8295
The Care Group, LLC *Recruiting*
Indianapolis, Indiana, 46290
United States
Recruiting George Daniel 317-583-6044
Cardiology, P.C. *Recruiting*
Birmingham, Alabama, 35211
United States
Recruiting Farrell Mendelsohn 205-780-4330
University of Chicago Hospitals *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting John Lopez 773-702-1719
Temple University *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting John Blebea 215-707-3622
University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Jorge Saucedo 405-271-4742
Jobst Vascular Center *Recruiting*
Toledo, Ohio, 43606
United States
Recruiting Anthony Comerota 419-291-2088
Yale University School of Medicine *Recruiting*
New Haven, Connecticut, 06510
United States
Recruiting Frank Giordano 203-785-7631
Falk Cardiovascular Research Center *Recruiting*
Stanford, California, 94305
United States
Recruiting Stanley Rockson 650-725-7571
American Cardiovascular Research Institute *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Nicolas Chronos 678-728-1957
Dartmouth - Hitchcock Medical Center *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting Richard Powell 603-650-8677
Access Clinical Trials *Recruiting*
Beverly Hills, California, 90210
United States
Recruiting Ronald Karlsberg 310-275-9551
The Lindner Clinical Trial Center *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting John Young 513-721-8881
NYPH-NY Weill Cornell Medical Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Peter Faries 212-746-3492
Brigham and Women's Hospital Division of Vascular Surgery *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Michael Conte 617-732-6816
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Christopher Kwolek 617-724-6101
Minneapolis Heart Institute Foundation *Recruiting*
Minneapolis, Minnesota, 55407
United States
Recruiting Timothy Henry 612-863-4788
Additional Information:
Study ID Numbers: AG-CLI-0202;
Study Start Date: April 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060892
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A safety and efficacy study of HGF via plasmid vector to improve perfusion in critical limb ischemia.
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