Evaluation of MST-188 in Acute Lower Limb Ischemia

NCT ID: NCT02093468

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.

Detailed Description

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Conditions

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Acute Limb Ischemia

Keywords

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Acute limb ischemia ALI Acute lower extremity arterial occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Saline

Saline administered IV for 12 hours

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Lower Dose

MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours

Group Type EXPERIMENTAL

MST-188

Intervention Type DRUG

Higher Dose

MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours

Group Type EXPERIMENTAL

MST-188

Intervention Type DRUG

Interventions

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MST-188

Intervention Type DRUG

Saline

Intervention Type DRUG

Other Intervention Names

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vepoloxamer

Eligibility Criteria

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Inclusion Criteria

* Age ≥30 to \<80
* Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb
* Subject is hospitalized or in the process of hospitalization for the treatment of ALI
* Angiographic confirmation of thrombotic lower limb arterial occlusion

Exclusion Criteria

* Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
* Treatment with a thrombolytic agent within the last 48 hours
* Subject's laboratory results indicate inadequate organ function
* NYHA Class IV congestive heart failure
* Prior major amputation of the target limb
* Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mast Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin L Parsley, D.O.

Role: STUDY_DIRECTOR

Mast Therapeutics, Inc.

Locations

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Research Center

Little Rock, Arkansas, United States

Site Status

Research Center

Tampa, Florida, United States

Site Status

Research Center

Brooklyn, New York, United States

Site Status

Research Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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MST-188-07

Identifier Type: -

Identifier Source: org_study_id