Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran

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

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

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Drug: Alprostadil liposomes for injection

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gu Yong quan, doctor; Phone Number: 010-83198605 15901598209; Email: 15901598209@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Gu Yongoing quan, doctor; Phone Number: 010-83198605 15901598209; Email: 15901598209@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intermittent claudication distance	Change of intermittent claudication distance from baseline after 2 weeks	After 2 weeks of treatment

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (ACTUAL): December 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arteriosclerosis; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: QLDE201901/PRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No