Overview

This trial is active, not recruiting.

Condition acute peripheral arterial occlusion
Treatments plasmin, plasminogen activator, placebo
Phase phase 2
Sponsor Grifols Therapeutics Inc.
Start date December 2010
End date December 2015
Trial size 230 participants
Trial identifier NCT01222117, 2010-019760-36, T05018-2004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Active Comparator)
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
plasminogen activator tissue plasminogen activator (tPA)
Plasminogen activator used according to the Investigator's clinical judgment.
(Placebo Comparator)
PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration
placebo Normal saline
Normal saline for injection at the same volume as the plasminogen activator.
(Experimental)
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection
(Experimental)
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
plasmin Plasmin (Human)
Plasmin prepared in 0.9% saline for injection

Primary Outcomes

Measure
The proportion of subjects with >50% thrombolysis
time frame: 5 hours

Secondary Outcomes

Measure
The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability.
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa - Onset of symptoms less than or equal to 14 days - Thrombosed infrainguinal bypass graft or native artery - Diagnosis by arteriography of occlusive thrombus in graft or artery - Ability to embed the infusion catheter into the thrombus - Women of childbearing potential must use contraception and have a negative pregnancy test Exclusion Criteria: - Any medical or social condition that may interfere with study participation - Women who are pregnant or lactating - Hemorrhagic stroke history - Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year - Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months - Major surgery, organ biopsy, or major trauma within the past 10 days - Lumbar puncture or non-compressible arterial puncture in the past 10 days - Intraocular surgery within the past 10 days - Active gastrointestinal or organ bleeding - Uncontrolled arterial hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) - Known intracranial neoplasm, aneurysm, or arteriovenous malformation - Current bleeding diathesis - Platelet count <75 x 10e9/L - Active graft infection - Occlusion occurred within one month of synthetic graft placement - Occlusion occurred within 6 months of autologous graft placement - A sequential composite graft with dual outflows to correct multiple occlusions - Medically unable to tolerate an open vascular procedure - Known prothrombotic state - Hemoglobin <10.0 g/dL - Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine >2.0 mg/dL - Treatment with a full dose plasminogen activator (PA) within the last 48 hours - Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days - Treatment with oral anticoagulants, and with an international normalized ratio of >1.7

Additional Information

Official title A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Grifols Therapeutics Inc..