Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran
Study Details
Study Description
Brief Summary
This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Alprostadil liposomes for injection
|
Drug: Alprostadil liposomes for injection
40ug,once a day,continuous administration for 2 weeks
|
| Active Comparator: KAISHI for injection
|
Drug: Alprostadil liposomes for injection
40ug,once a day,continuous administration for 2 weeks
|
Outcome Measures
Primary Outcome Measures
- intermittent claudication distance [After 2 weeks of treatment]
Change of intermittent claudication distance from baseline after 2 weeks
Eligibility Criteria
Criteria
Inclusion Criteria:
-
40 <age ≤ 80 years ，regardless of gender;
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Agree to participate in this clinical trial and sign the informed consent voluntarily;
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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;
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Ankle-brachial index (ABI) <0.9;
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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);
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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.
Exclusion Criteria:
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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;
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Combining a history of stroke or cerebral hemorrhage, the judgment of researchers will affect the safety evaluation of efficacy;
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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;
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Obesity (BMI≥40);
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Fontaine stage is IV, or patients with severe resting pain need to use strong analgesics or surgical amputation;
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Hepatic impairment (ALT or AST ≥ 3 times ULN) or primary liver disease;
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Renal dysfunction, SCr> 1.5 times the upper limit of normal value;
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Poorly controlled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
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Diabetic patients with poor control (HbA1c> 9%);
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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.);
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Patients who have successfully received walking rehabilitation training in the past 6 months;
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There are other diseases that significantly affect the walking distance, such as lower extremity joint disease, spinal disease, neuropathyt;
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Patients with inflammatory vascular diseases, such as multiple arteritis, peripheral edema, thrombo-occlusive vasculitis, etc .;
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Patients with total femoral or above, femoropopliteal artery occlusion, or above groin artery occlusion;
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Patients with active peptic ulcer or bleeding tendency;
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Glaucoma or hypertensive patients;
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Patients who have used powerful analgesics (such as morphine) in the nearly a month;
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Patients with mental illness or dementia;
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Patients with malignant tumors;
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Patients with previous allergies to similar products;
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Those who have participated in drug clinical trials in the past 3 months;
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Patients who are pregnant or nursing, or patients who are unable to perform effective contraception during the study period;
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Active hepatitis B virus infection (HBV surface antigen positive and (HBVDNA quantification ≥1 × 103copies / mL), hepatitis C virus, syphilis antibody and HIV antibody positive;
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Other patients considered by investigators to be unsuitable for this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xuanwu Hospital Capital Medical University | Beijing | Beijing | China | 100000 |
Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QLDE201901/PRO