Evaluation of MST-188 in Acute Lower Limb Ischemia

Acute Limb Ischemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02093468
• Other study ID #: MST-188-07
• Status: Terminated
• Phase: Phase 2
• First received: March 18, 2014
• Last updated: December 11, 2015
• Start date: June 2014

Study information

• Verified date: December 2015
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Limb Ischemia
• Ischemia

Intervention

Drug:
• MST-188

• Saline

Locations

Country	Name	City	State
United States	Research Center	Brooklyn	New York
United States	Research Center	Cleveland	Ohio
United States	Research Center	Little Rock	Arkansas
United States	Research Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)		Baseline, 8 and 24 hours	No
Primary	Assessment of the change in TcPO2 (Exploratory endpoint)		Baseline, 8, 12, and 24 hours	No
Primary	Number of participants with adverse events		Randomization through 30 days post-treatment	Yes