Evaluation of MST-188 in Acute Lower Limb Ischemia

NCT02093468 | Terminated Phase 2 DMC

• 1 other identifier: MST-188-07
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Limb Ischemia

Keywords

Acute limb ischemia; ALI; Acute lower extremity arterial occlusion

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Saline

PLACEBO COMPARATOR

Saline administered IV for 12 hours

Drug: Saline

Lower Dose

EXPERIMENTAL

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

Drug: MST-188

Higher Dose

EXPERIMENTAL

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

Drug: MST-188

Interventions

MST-188 DRUG

Also known as: vepoloxamer

Higher Dose; Lower Dose

Saline DRUG

Saline

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mast Therapeutics, Inc.: lead

Study Sites (4)

Research Center

Little Rock, Arkansas, 72205, United States

Location

Research Center

Tampa, Florida, 33606, United States

Location

Research Center

Brooklyn, New York, 11219, United States

Location

Research Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Edwin L Parsley, D.O.

  Mast Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 21, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

US (4)