Evaluation of MST-188 in Acute Lower Limb Ischemia

Phase 2

Terminated

• Conditions: Acute Limb Ischemia
• Interventions: Drug: Saline; Drug: MST-188

• Registration Number: NCT02093468
• Lead Sponsor: Mast Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Study Start: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-11
• Last Update Posted: 2015-12-15
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline administered IV for 12 hours
Lower Dose	MST-188	MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours
Higher Dose	MST-188	MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Center; 🇺🇸 Cleveland, Ohio, United States