CTRI/2011/11/002177进行中（未招募）2 期
A Phase IIa Randomized Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection to Cohorts of Adults with Critical Limb Ischemia
Juventas Therapeutics0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Men or women 40 years of age or older
- •2)Rutherford category 4 or 5
- •a)Subjects with focal gangrene on the big toe of the ischemic leg will also be considered for enrollment
- •3)Ankle systolic pressure of 70 mm Hg or less, or toe systolic pressure of 50 mm Hg or less
- •a)Note: For subjects with absolute ankle and toe pressures in the affected limb that are unreliable (e.g., non-compressible arteries due to calcification) or unattainable (e.g., non-healing ulcers on ankle or great toe which prevent this assessment), there must be documentation of a clinical diagnosis of Rutherford Class 4 or 5 Critical Limb Ischemia and angiographic evidence of the total occlusion of the superficial femoral, popliteal or at least one of the infra-popliteal arteries.
- •4)Poor option for surgical revascularization by open or endovascular strategies as determined by the treating physician. A narrative documenting the reason why the subject is a poor candidate for revascularization must be included in the subjects medical record
- •5)Those diabetic subjects who are on optimal diabetes medication, with HbA1c < 8.5%
- •6)Subject should be on stable medical therapy for the treatment of CLI, including statin and anti platelet therapy unless there is documented contraindication or intolerance to these therapies
- •7)Subject must be willing to forego treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of CLI from 10 days prior to 45 days following injection of study drug
- •8)Willing and able to sign informed consent
排除标准
- •1)Life expectancy of less than one year
- •2)Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment
- •3)Patent revascularization (within 6 weeks) in the leg to be treated prior to enrollment
- •4)NYHA Class IV heart failure
- •5)Evidence of osteomyelitis or active infection
- •6)Uncontrolled blood pressure defined as SBP>= 180 mmHg or DBP >=110 mmHg despite adequate antihypertensive treatment at time of screening or enrollment
- •7)Significant hepatic disease (defined as >3-fold elevation in ALT/AST), HBV or HCV carriers
- •8)Diabetic subjects with active proliferative retinopathy
- •9)Immunodeficient states (e.g. known HIV positivity, or organ transplant recipient) or subject receiving chronic immunosuppressive therapy. Subjects receiving steroid inhalers are allowed.
- •10)Any patient with a history of cancer will be excluded unless:
- •a)The cancer was limited to curable non-melanoma skin malignancies
- •b)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.
- •11)Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control (see section 8.2.1 for list of effective methods)
- •12)Men unwilling to agree to barrier contraception or limit sexual activity
- •13)Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
- •14)Acute coronary syndrome within 3 months prior to enrollment
- •15)Previous treatment with angiogenic growth factors or with stem cell therapy within 1 year
- •16)Participation in another clinical trial in the last 30 days
- •17)Clinically significant elevations in PT/PTT/INR as judged by the site investigator
- •18)Non-heel wound size > 20cm2 (excluding toe gangrene) or heel would size >10cm2 on the index leg as measured by the Wound Core Lab from photograph and/or acetate tracing collecte at acreening
- •19)History of drug or alcohol abuse within the last year
- •20)Participation in another clinical trial in the last 30 days
- •21)Any subject who is unfit for the trial based on the discretion of the site Principal Investigator
研究者
相似试验
进行中（未招募）
1 期
A Phase II Randomised, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Mexiletine in Patients with Non-Dystrophic Myotonia. - Mexiletine in Non-Dystrophic MyotoniaEUCTR2009-011184-36-GBniversity College London-Joint UCLH/UCL Biomedical (R&D) Unit60
进行中（未招募）
1 期
A study to evaluate efficacy and safety of ASP8232 as add-on therapy to the standard of care in patients with Type 2 Diabetes and Chronic Kidney Disease.MedDRA version: 19.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersDiabetic nephropathyEUCTR2014-002349-23-PLAstellas Pharma Europe BV (APEB)110
进行中（未招募）
1 期
A study to evaluate efficacy and safety of ASP8232 as add-on therapy to the standard of care in patients with Type 2 Diabetes and Chronic Kidney Disease.Diabetic nephropathyMedDRA version: 18.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2014-002349-23-DKAstellas Pharma Europe BV (APEB)110
进行中（未招募）
1 期
A study to evaluate efficacy and safety of ASP8232 as add-on therapy to the standard of care in patients with Type 2 Diabetes and Chronic Kidney Disease.MedDRA version: 18.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersDiabetic nephropathyEUCTR2014-002349-23-GBAstellas Pharma Europe BV (APEB)110
进行中（未招募）
1 期
A clinical trial with GS-6615 for treatment of Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)EUCTR2013-004430-15-DKGilead Sciences, Inc.270