A Dose Escalation and Safety Study of Plasmin (Human) In Acute Lower Extremity Native Artery or Bypass Graft Occlusion (PRIORITY)
28 oktober 2016 bijgewerkt door: Grifols Therapeutics LLC
A Sequential Phase I/II Dose Escalation and Dose Selection Safety Study of Regional Intra-thrombus Plasmin (Human) Infusion In Acute Lower Extremity Native Artery or Bypass Graft Occlusion
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
83
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Toledo, Ohio, Verenigde Staten, 43606
- Jobst Vascular Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Plasmin (Human) 25 mg
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Plasmin (Human) 25 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Andere namen:
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Experimenteel: Plasmin (Human) 50 mg
Plasmin (Human ) 50 mg
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Plasmin (Human) 50 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Andere namen:
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Experimenteel: Plasmin (Human) 75 mg
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Plasmin (Human) 75 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Andere namen:
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Experimenteel: Plasmin (Human) 100 mg
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Plasmin (Human) 100 mg
Andere namen:
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Experimenteel: Plasmin (Human) 125 mg
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Plasmin (Human) 125 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Andere namen:
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Experimenteel: Plasmin (Human) 150 mg
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Plasmin (Human) 150 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Andere namen:
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Experimenteel: Plasmin (Human) 175 mg
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Plasmin (Human) 175 mg delivered via an infusion catheter into the thrombus over approximately 5 hours.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Thrombolysis
Tijdsspanne: Approximately 5 hours after start of treatment
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Thrombolysis at the end of treatment compared to baseline by arteriography
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Approximately 5 hours after start of treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Thrombolysis
Tijdsspanne: Approximately 2 hours after start of treatment
|
Thrombolysis at 120 minutes compared to baseline by arteriography
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Approximately 2 hours after start of treatment
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|
Avoidance of open surgical procedures
Tijdsspanne: 30 days
|
Percent of subjects at Day 30 who avoid open surgical procedures
|
30 days
|
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Avoidance of amputation
Tijdsspanne: 30 days
|
Percent of subjects at Day 30 who avoid amputation
|
30 days
|
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Avoidance of additional catheter-directed thrombolysis with a plasminogen activator or mechanical device thrombectomy
Tijdsspanne: 30 days
|
Percent of subjects at Day 30 who avoided additional catheter-directed thrombolysis with a plasminogen activator or mechanical device thrombectomy.
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30 days
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Avoidance of both open surgical procedures and additional thrombolysis with a plasminogen activator or mechanical device thrombectomy.
Tijdsspanne: 30 days
|
Percent of subjects at Day 30 who avoided both open surgical procedures and additional thrombolysis with a plasminogen activator or mechanical device thrombectomy.
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30 days
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Physiologic reperfusion defined as improvement in ankle brachial index (ABI)
Tijdsspanne: End of treatment, post intervention procedures, Day 1 to 2, Day 7, and Day 30
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Physiologic reperfusion defined as improvement in ABI (increase of ≥ 0.15) determined at the end of treatment, post intervention procedures, Day 1 to 2, Day 7, and Day 30.
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End of treatment, post intervention procedures, Day 1 to 2, Day 7, and Day 30
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Patency assessed by duplex ultrasound imaging
Tijdsspanne: Day 7 and Day 30
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Patency assessed by duplex ultrasound imaging on the affected leg on Day 7 and Day 30
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Day 7 and Day 30
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Anthony J Comerota, MD, Jobst Vascular Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2007
Primaire voltooiing (Werkelijk)
1 april 2010
Studie voltooiing (Werkelijk)
1 april 2010
Studieregistratiedata
Eerst ingediend
2 januari 2007
Eerst ingediend dat voldeed aan de QC-criteria
2 januari 2007
Eerst geplaatst (Schatting)
4 januari 2007
Updates van studierecords
Laatste update geplaatst (Schatting)
31 oktober 2016
Laatste update ingediend die voldeed aan QC-criteria
28 oktober 2016
Laatst geverifieerd
1 oktober 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 050003
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