Evaluation of MST-188 in Acute Lower Limb Ischemia

Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator

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.

Study Overview

• Status: Terminated
• Conditions: Acute Limb Ischemia
• Intervention / Treatment: Drug: Saline; Drug: MST-188

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Research Center
  • New York
    • Brooklyn, New York, United States, 11219
      • Research Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Saline administered IV for 12 hours	Drug: Saline
Experimental: Lower Dose; MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours	Drug: MST-188; Other Names: vepoloxamer
Experimental: Higher Dose; MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours	Drug: MST-188; Other Names: vepoloxamer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)	Baseline, 8 and 24 hours
Assessment of the change in TcPO2 (Exploratory endpoint)	Baseline, 8, 12, and 24 hours
Number of participants with adverse events	Randomization through 30 days post-treatment

Collaborators and Investigators

• Sponsor: Mast Therapeutics, Inc.
• Investigators: Study Director: Edwin L Parsley, D.O., Mast Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: ALI; Acute limb ischemia; Acute lower extremity arterial occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: MST-188-07