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Evaluation of MST-188 in Acute Lower Limb Ischemia

Primary Purpose

Acute Limb Ischemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MST-188
Saline
Sponsored by
Mast Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Limb Ischemia focused on measuring Acute limb ischemia, ALI, Acute lower extremity arterial occlusion

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Center
  • Research Center
  • Research Center
  • Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Saline

Lower Dose

Higher Dose

Arm Description

Saline administered IV for 12 hours

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

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

Outcomes

Primary Outcome Measures

Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
Assessment of the change in TcPO2 (Exploratory endpoint)
Number of participants with adverse events

Secondary Outcome Measures

Full Information

First Posted
March 18, 2014
Last Updated
December 11, 2015
Sponsor
Mast Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02093468
Brief Title
Evaluation of MST-188 in Acute Lower Limb Ischemia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Program discontinued to persue alternate indications.
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mast Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Limb Ischemia
Keywords
Acute limb ischemia, ALI, Acute lower extremity arterial occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline administered IV for 12 hours
Arm Title
Lower Dose
Arm Type
Experimental
Arm Description
MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours
Arm Title
Higher Dose
Arm Type
Experimental
Arm Description
MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours
Intervention Type
Drug
Intervention Name(s)
MST-188
Other Intervention Name(s)
vepoloxamer
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)
Time Frame
Baseline, 8 and 24 hours
Title
Assessment of the change in TcPO2 (Exploratory endpoint)
Time Frame
Baseline, 8, 12, and 24 hours
Title
Number of participants with adverse events
Time Frame
Randomization through 30 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin L Parsley, D.O.
Organizational Affiliation
Mast Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Research Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Research Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Evaluation of MST-188 in Acute Lower Limb Ischemia

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