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

Grifols logo

Grifols

Status and phase

Completed
Phase 2

Conditions

Acute Peripheral Arterial Occlusion

Treatments

Biological: Plasminogen Activator
Biological: Plasmin
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01222117
2010-019760-36 (EudraCT Number)
T05018-2004

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

174 participants in 11 patient groups, including a placebo group

Plasmin Open-label Treatment Group A
Experimental group
Description:
Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group B
Experimental group
Description:
Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group C
Experimental group
Description:
Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group D
Experimental group
Description:
Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate
Treatment:
Biological: Plasmin
Plasminogen Activator Blinded Group E
Active Comparator group
Description:
PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice
Treatment:
Biological: Plasminogen Activator
PA Placebo Blinded Treatment Arm F
Placebo Comparator group
Description:
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
Treatment:
Other: Placebo
Plasmin Open-label Treatment Group G
Experimental group
Description:
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group H
Experimental group
Description:
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group I
Experimental group
Description:
Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group J
Experimental group
Description:
Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter
Treatment:
Biological: Plasmin
Plasmin Open-label Treatment Group M
Experimental group
Description:
Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter
Treatment:
Biological: Plasmin

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems