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A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion

NCT ID: NCT00418483

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to evaluate the safety of increasing doses of intra-thrombus Plasmin (Human) in acute peripheral arterial occlusion (aPAO). The ability of these Plasmin doses to dissolve the clots will be estimated by arteriography.

Detailed Description

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There is an unmet need for proven thrombolytic agent in acute peripheral arterial occlusion (aPAO). The current assortment of plasminogen activators are slow to dissolve clots in the leg, and may lead to bleeding complications. Plasmin is a direct thrombolytic that may act more quickly when infused directly into the clot and thus assist in restoring blood flow to the leg. There is a large reserve in blood alpha-2 antiplasmin in the blood to rapidly inactivate Plasmin outside of the clot. Plasmin has the potential for an improved bleeding risk profile in aPAO.

Conditions

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Arterial Occlusive Diseases

Keywords

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thrombolytic thrombolysis acute peripheral arterial occlusion peripheral vascular disease thrombosis endovascular

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plasmin (Human) 25 mg

Plasmin (Human) 25 mg

Group Type EXPERIMENTAL

Plasmin (Human) 25 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Plasmin (Human) 50 mg

Plasmin (Human ) 50 mg

Group Type EXPERIMENTAL

Plasmin (Human) 50 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Plasmin (Human) 75 mg

Plasmin (Human) 75 mg

Group Type EXPERIMENTAL

Plasmin (Human) 75 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Plasmin (Human) 100 mg

Plasmin (Human) 100 mg

Group Type EXPERIMENTAL

Plasmin (Human) 100 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 100 mg

Plasmin (Human) 125 mg

Plasmin (Human) 125 mg

Group Type EXPERIMENTAL

Plasmin (Human) 125 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Plasmin (Human) 150 mg

Plasmin (Human) 150 mg

Group Type EXPERIMENTAL

Plasmin (Human) 150 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Plasmin (Human) 175 mg

Plasmin (Human) 175 mg

Group Type EXPERIMENTAL

Plasmin (Human) 175 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Interventions

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Plasmin (Human) 25 mg

Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Intervention Type BIOLOGICAL

Plasmin (Human) 50 mg

Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Intervention Type BIOLOGICAL

Plasmin (Human) 75 mg

Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Intervention Type BIOLOGICAL

Plasmin (Human) 100 mg

Plasmin (Human) 100 mg

Intervention Type BIOLOGICAL

Plasmin (Human) 125 mg

Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Intervention Type BIOLOGICAL

Plasmin (Human) 150 mg

Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Intervention Type BIOLOGICAL

Plasmin (Human) 175 mg

Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.

Intervention Type BIOLOGICAL

Other Intervention Names

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TAL-05-00018 BAY-57-9602 TAL-05-00018 BAY-57-9602 TAL-05-00018 BAY-57-9602 TAL-05-00018 BAY-57-9602 TAL-05-00018 BAY-57-9602 TAL-05-00018 BAY-57-9602 TAL-05-00018 BAY-57-9602

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* Women of childbearing potential must use adequate contraception for the duration of the study and must have a negative pregnancy test prior to study entry.
* Unilateral limb ischemia: SVS acute ischemia Category I or IIa.
* Onset of symptoms \</= 14 days.
* Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, only occlusions of ≥ 10 cm in length are eligible.
* Diagnosis of occlusive thrombus in the graft or artery by arteriography after Informed Consent is obtained.
* Ability to traverse the thrombus with a guidewire.
* Signed informed consent prior to study entry.

Exclusion Criteria

* Clinical evidence of significant disease that may interfere with the patient successfully completing the trial.
* Women who are pregnant or lactating, or first 10 days post-partum.
* Previous hemorrhagic stroke at any time. Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack (TIA)) within one year.
* Intracranial or spinal neuro-surgery, or severe intracranial trauma in the last 3 months. Major surgery, organ biopsy, or major trauma within the last 10 days. Lumbar puncture or non-compressible arterial puncture in the last 10 days. Intra-ocular surgery within the last 10 days.
* Current bleeding diathesis. Active gastrointestinal or organ bleeding. Minor bleeding such as normal menses, cystitis, or minor hemorrhoidal bleeding are not exclusions.
* Uncontrolled arterial hypertension, defined as a systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg.
* Known intracranial neoplasm, aneurysm, or arterio-venous malformation.
* Platelet count \< 75 x 10e9/L.
* Occlusion of a graft within 6 months of placement.
* Medically unable to tolerate an open vascular procedure.
* Known prothrombotic condition.
* Hemoglobin \<10.0 g/dL
* Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine \> 2.0 mg/dL or subjects on renal dialysis.
* Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days, for example, abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban (Aggrastat®).
* Treatment with warfarin (Coumadin®) and with an INR of \>1.7 (elevated INR at screening may be corrected prior to study enrollment.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grifols Therapeutics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony J Comerota, MD

Role: PRINCIPAL_INVESTIGATOR

Jobst Vascular Center

Locations

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Jobst Vascular Institute

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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050003

Identifier Type: -

Identifier Source: org_study_id