Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran

NCT ID: NCT04197323

Last Updated: 2019-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-06-01

Brief Summary

This is a randomized, positive-control, multicenter, multiple-dose, dose-escalation phase II trial

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alprostadil liposomes for injection

Group Type: EXPERIMENTAL

Alprostadil liposomes for injection

Intervention Type: DRUG

40ug,once a day,continuous administration for 2 weeks

KAISHI for injection

Group Type: ACTIVE_COMPARATOR

Alprostadil liposomes for injection

Intervention Type: DRUG

40ug,once a day,continuous administration for 2 weeks

Interventions

Alprostadil liposomes for injection

40ug,once a day,continuous administration for 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 40 <age ≤ 80 years ，regardless of gender;

2. Agree to participate in this clinical trial and sign the informed consent voluntarily;

3. 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;

4. Ankle-brachial index (ABI) <0.9;

5. 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);

6. 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

1. 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;

2. Combining a history of stroke or cerebral hemorrhage, the judgment of researchers will affect the safety evaluation of efficacy;

3. 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;

4. Obesity (BMI≥40);

5. Fontaine stage is IV, or patients with severe resting pain need to use strong analgesics or surgical amputation;

6. Hepatic impairment (ALT or AST ≥ 3 times ULN) or primary liver disease;

7. Renal dysfunction, SCr> 1.5 times the upper limit of normal value;

8. Poorly controlled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);

9. Diabetic patients with poor control (HbA1c> 9%);

10. 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.);

11. Patients who have successfully received walking rehabilitation training in the past 6 months;

12. There are other diseases that significantly affect the walking distance, such as lower extremity joint disease, spinal disease, neuropathyt;

13. Patients with inflammatory vascular diseases, such as multiple arteritis, peripheral edema, thrombo-occlusive vasculitis, etc .;

14. Patients with total femoral or above, femoropopliteal artery occlusion, or above groin artery occlusion;

15. Patients with active peptic ulcer or bleeding tendency;

16. Glaucoma or hypertensive patients;

17. Patients who have used powerful analgesics (such as morphine) in the nearly a month;

18. Patients with mental illness or dementia;

19. Patients with malignant tumors;

20. Patients with previous allergies to similar products;

21. Those who have participated in drug clinical trials in the past 3 months;

22. Patients who are pregnant or nursing, or patients who are unable to perform effective contraception during the study period;

23. Active hepatitis B virus infection (HBV surface antigen positive and (HBVDNA quantification ≥1 × 103copies / mL), hepatitis C virus, syphilis antibody and HIV antibody positive;

24. Other patients considered by investigators to be unsuitable for this trial.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Gu Yong quan, doctor

Role: CONTACT

Phone: 15901598209

Email: 15901598209@163.com

Facility Contacts

Gu Yongoing quan, doctor

Role: primary

Other Identifiers

QLDE201901/PRO

Identifier Type: -

Identifier Source: org_study_id