Clinical Trial: A Safety/Efficacy Study of Alprostadil Liposomes for Injection to Treat Lower Extremity Arteriosclerosis Obliterans

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Alprostadil Liposomes for Injection in the Treatment of Atherosclerotic Occlusive Disease of the Lower Extremities—A Phase II Multi-center Randomised Controlled Trial

Brief Summary: A phase II,randomized,double-blind,multi-doses,positive drug parallel controlled,multi-center clinical trial to evaluate initially the efficacy and safety of alprostadil liposomes for injection in the treatment of atherosclerotic occlusive disease of the lower extremities.

Detailed Summary:

This is a phase 2 dose-finding study evaluating initially the efficacy and safety of alprostadil liposomes for injection in the treatment of atherosclerotic occlusive disease of the lower extremities at different dose strengths.The total duration of subject participation will be approximately 5 weeks,consisting of a 2-week run-in period,3-week treatment and safety follow-up period.

Subjects will sign the informed consent form(ICF) at a screening visit and will be assigned a subject identifier.Subjects meeting all inclusion/exclusion criteria and who have successfully completed all protocol procedures at screening will enter the 2-week run-in.Following the 2-week run-in period,eligible subjects will be randomized(1:1:1:1) to one of the following double-blind treatment groups:

Group A : Alprostadil Liposomes for Injection at low dose:20ug,once a day(QD); Group B : Alprostadil Liposomes for Injection at medium dose:40ug,QD Group C : Alprostadil Liposomes for Injection at high dose:60ug,QD Group D(Positive Control Group) : Alprostadil Injection:10ug,QD All treatments will be delivered by intravenously guttae.A subject will be consider to have completed the study when they have completed all phase of the study including run-in,randomization,the randomized treatment and efficacy and safety follow-up phase.


Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD

Current Primary Outcome: Change from baseline in distance of asymptomatic disease and claudication after 3 weeks of treatment. [ Time Frame: After 3 weeks of treatment ]

Unit of distance of asymptomatic disease and claudication:meters


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in maximun distance of claudication after 3 weeks of treatment. [ Time Frame: After 3 weeks of treatment ]
    Unit of maximun distance of claudication :meters
  • Change from baseline in distance of asymptomatic disease and claudication and in maximum distance of claudication after 2 weeks of treatment. [ Time Frame: After 2 weeks of treatment ]
    Unit of distance of asymptomatic disease and claudication:meters
  • The proportion of patients to treatment failure. [ Time Frame: After 3 weeks of treatment ]
    The treatment failure is defined as arteriosclerosis obliterans(ASO) exacerbation that has necessary to change chemotherapy or have interventional operation.
  • Incidence of Adverse Events(AEs) [ Time Frame: over 3 weeks of treatment ]

    The safety endpoints for this study include:

    1. AEs
    2. Vital Sign Measurements
    3. Physical examination
    4. Clinical Laboratory Evaluations


Original Secondary Outcome: Same as current

Information By: Guangzhou Yipinhong Pharmaceutical CO.,LTD

Dates:
Date Received: August 16, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: March 8, 2017
Last Verified: March 2017