Evaluation of MST-188 in Acute Lower Limb Ischemia

Mast Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Acute Limb Ischemia

Treatments: Drug: Saline; Drug: MST-188

Study type: Interventional

Funder types: Industry

Identifiers

NCT02093468

MST-188-07

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 3 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Saline administered IV for 12 hours

Treatment:

Drug: Saline

Lower Dose

Experimental group

Description:

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

Treatment:

Drug: MST-188

Higher Dose

Experimental group

Description:

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

Treatment:

Drug: MST-188