Evaluation of MST-188 in Acute Lower Limb Ischemia

• Sponsor: Mast Therapeutics, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02093468
• Collaborator: (none)
• Enrollment: 4
• Locations: 4
• Arms: 3
• Patient Per Site: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Limb Ischemia	Drug: MST-188; Drug: Saline	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint) [Baseline, 8 and 24 hours]

2. Assessment of the change in TcPO2 (Exploratory endpoint) [Baseline, 8, 12, and 24 hours]

3. Number of participants with adverse events [Randomization through 30 days post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Center	Little Rock	Arkansas	United States	72205
2	Research Center	Tampa	Florida	United States	33606
3	Research Center	Brooklyn	New York	United States	11219
4	Research Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Mast Therapeutics, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mast Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02093468
• Other Study ID Numbers: MST-188-07
• First Posted: Mar 21, 2014
• Last Update Posted: Dec 15, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Mast Therapeutics, Inc.: Acute limb ischemia; ALI; Acute lower extremity arterial occlusion
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Dec 15, 2015