Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran

Peripheral Artery Disease Clinical Trial

Official title:

Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran of Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197323
• Other study ID #: QLDE201901/PRO
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2019
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: Gu Yong quan, doctor
• Phone: 15901598209
• Email: 15901598209[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Alprostadil liposomes for injection
40ug,once a day,continuous administration for 2 weeks

Locations

Country	Name	City	State
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intermittent claudication distance	Change of intermittent claudication distance from baseline after 2 weeks	After 2 weeks of treatment