NCT04197323Unknown2 期
Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran of Phase II Clinical Trial
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- intermittent claudication distance
研究概览
简要总结
This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial
详细描述
A randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial. The trial was divided into 4 dose groups: the positive drug Kaishi 10 μg group and the alprostadil liposome for injection 40μg, 80μg, 120μg group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 <age ≤ 80 years ，regardless of gender;
- •Agree to participate in this clinical trial and sign the informed consent voluntarily;
- •Meet the diagnostic criteria of lower extremity arteriosclerosis obliteran (lower extremity ASO) (according to the definition of the 2015 Chinese lower extremity arteriosclerosis obliteran diagnosis and treatment guidelines), which are: age> 40 years; have clinical manifestations of lower extremity arteriosclerosis obliteran ; Weakness or disappearance of distal arterial pulsation in ischemic limbs;
- •Ankle-brachial index (ABI) <0.9;
- •Fontaine stage II or III. For subjects with Fontaine stage II, intermittent claudication distance is between 50m and 800m (fixed plate speed 3km / h, slope 12%); and at least 2 tests with difference of ≤25% (comparison based on the first measurement value, the second measurement is performed after the subject is fully rested the next day and after);
- •Imaging examinations such as color Doppler ultrasound, CTA, MRA, or DSA within 1 month before enrollment revealed lesions such as stenosis or occlusion of the corresponding lower limb arteries.
排除标准
- •Patients with pre-existing cardiac dysfunction, such as untreated heart failure, arrhythmia, coronary heart disease, mitral or aortic stenosis, or a history of myocardial infarction within the last 6 months;
- •Combining a history of stroke or cerebral hemorrhage, the judgment of researchers will affect the safety evaluation of efficacy;
- •Patients diagnosed or suspected of having pulmonary edema, pulmonary infiltration, or interstitial pneumonia through clinical or related examinations, or those with severe chronic obstructive ventilation disorder or respiratory insufficiency;
- •Obesity (BMI≥40);
- •Fontaine stage is IV, or patients with severe resting pain need to use strong analgesics or surgical amputation;
- •Hepatic impairment (ALT or AST ≥ 3 times ULN) or primary liver disease;
- •Renal dysfunction, SCr> 1.5 times the upper limit of normal value;
- •Poorly controlled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- •Diabetic patients with poor control (HbA1c> 9%);
- •Patients with a history of interventional or bypass surgery or endovascular treatment in the past 3 months; or those who have stopped using prostaglandins for less than 5 half-life of the corresponding drugs; Elderly within 5 half-life of the corresponding drug (such as naphthylamine, pentoxifylline, butrodil, cilostazol, etc.);
- •Patients who have successfully received walking rehabilitation training in the past 6 months;
- •There are other diseases that significantly affect the walking distance, such as lower extremity joint disease, spinal disease, neuropathyt;
- •Patients with inflammatory vascular diseases, such as multiple arteritis, peripheral edema, thrombo-occlusive vasculitis, etc .;
- •Patients with total femoral or above, femoropopliteal artery occlusion, or above groin artery occlusion;
- •Patients with active peptic ulcer or bleeding tendency;
- •Glaucoma or hypertensive patients;
- •Patients who have used powerful analgesics (such as morphine) in the nearly a month;
- •Patients with mental illness or dementia;
- •Patients with malignant tumors;
- •Patients with previous allergies to similar products;
- •Those who have participated in drug clinical trials in the past 3 months;
- •Patients who are pregnant or nursing, or patients who are unable to perform effective contraception during the study period;
- •Active hepatitis B virus infection (HBV surface antigen positive and (HBVDNA quantification ≥1 × 103copies / mL), hepatitis C virus, syphilis antibody and HIV antibody positive;
- •Other patients considered by investigators to be unsuitable for this trial.
研究组 & 干预措施
Alprostadil liposomes for injection
Experimental
干预措施: Alprostadil liposomes for injection (Drug)
KAISHI for injection
Active Comparator
干预措施: Alprostadil liposomes for injection (Drug)
结局指标
主要结局
intermittent claudication distance
时间窗: After 2 weeks of treatment
Change of intermittent claudication distance from baseline after 2 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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