Alprostadil Liposomes for Injection for Lower Extremity Arteriosclerosis Obliteran

NCT04197323 | Unknown Phase 2

• 1 other identifier: QLDE201901/PRO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• intermittent claudication distance

  Change of intermittent claudication distance from baseline after 2 weeks

  After 2 weeks of treatment

Study Arms (2)

Alprostadil liposomes for injection

EXPERIMENTAL

Drug: Alprostadil liposomes for injection

KAISHI for injection

ACTIVE COMPARATOR

Drug: Alprostadil liposomes for injection

Interventions

Alprostadil liposomes for injection DRUG

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

Alprostadil liposomes for injection; KAISHI for injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Injections

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Gu Yong quan, doctor

CONTACT

15901598209; 15901598209@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: October 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

CN (1)