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A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion

NCT01222117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2017-01-16

Study results available
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Summary

The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.

Conditions

  • Acute Peripheral Arterial Occlusion

Interventions

BIOLOGICAL

Plasmin

Plasmin prepared in 0.9% saline for injection

BIOLOGICAL

Plasminogen Activator

Plasminogen activator used according to the Investigator's clinical judgment.

OTHER

Placebo

Normal saline for injection at the same volume as the plasminogen activator.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Kecia Courtney · Grifols Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • United States
  • Belgium
  • Bulgaria
  • Czechia
  • Germany
  • India
  • Peru
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222117 on ClinicalTrials.gov